Mintek Pacemaker LV User Manual

Stratos

Family of Cardiac Resynchronization

Therapy Pacemakers

Technical Manual

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Stratos LV/LV-T Technical Manual i

Contents

1. General ..............................................................................1

1.1 Device Description ........................................................1

1.2 Indications .....................................................................2

1.3 Contraindications ..........................................................3

1.4 Note to Physician ..........................................................3

1.5 Warnings and Precautions............................................3

1.5.1 Interactions with Other Medical Therapy...............4

1.5.2 Storage and Sterilization .......................................6

1.5.3 Lead Connection and Evaluation ..........................7

1.5.4 Programming and Operation.................................8

1.5.5 Home Monitoring.................................................11

1.5.6 Electromagnetic Interference (EMI) ....................13

1.5.7 Home and Occupational Environments...............13

1.5.8 Cellular Phones...................................................14

1.5.9 Hospital and Medical Environments....................15

1.5.10 Device Explant and Disposal...............................15

1.6 Potential Effects of the Device on Health....................16

1.7 Clinical Studies............................................................17

1.7.1 Stratos LV Clinical Study – AVAIL CLS/CRT......17

1.7.2 Stratos LV Clinical Study – OVID study ..............39

1.7.3 AVAIL and OVID Combined Primary

Endpoint-Complication-free Rate (Safety) ..........47

1.7.4 Tupos LV/ATx Clinical IDE Study -

OPTION CRT/ATx...............................................49

1.7.5 Conclusions Drawn from Studies........................61

2. Programmable Parameters............................................63

2.1 Pacing Modes..............................................................63

2.1.1 Rate-adaptive Modes ..........................................63

2.1.2 DDD.....................................................................63

2.1.3 DDI ......................................................................67

2.1.4 DVI.......................................................................67

2.1.5 VDD.....................................................................67

2.1.6 AAI and VVI.........................................................68

2.1.7 AAI, VVI...............................................................68

2.1.8 AOO, VOO...........................................................68

2.1.9 DOO ....................................................................68

2.1.10 VDI.......................................................................68

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ii Stratos LV/LV-T Technical Manual

2.1.11 OFF (ODO)..........................................................69

2.2 Biventricular Synchronization of the Stratos CRT-Ps..69

2.3 Timing Functions.........................................................70

2.3.1 Basic Rate ...........................................................70

2.3.2 Rate Hysteresis ...................................................71

2.3.3 Scan Hysteresis...................................................72

2.3.4 Repetitive Hysteresis...........................................74

2.3.5 Night Mode ..........................................................75

2.3.6 Refractory Periods...............................................76

2.3.7 Atrial PMT Protection...........................................77

2.3.8 Ventricular Refractory Period ..............................78

2.3.9 AV Delay..............................................................78

2.3.10 VES Discrimination after Atrial Sensed Events...80

2.3.11 Sense Compensation..........................................80

2.3.12 Ventricular Blanking Period.................................81

2.3.13 Safety AV Delay ..................................................81

2.4 Pacing and Sensing Functions....................................82

2.4.1 Pulse Amplitude and Pulse Width .......................82

2.4.2 Sensitivity ............................................................83

2.4.3 Lead Polarity........................................................83

2.5 Automatic Lead Check................................................84

2.6 Antitachycardia Functions:..........................................86

2.6.1 Upper Rate and UTR Response .........................86

2.7 Wenckebach 2:1..........................................................86

2.8 Mode Switching...........................................................88

2.9 PMT Management.......................................................89

2.9.1 Protection ............................................................89

2.9.2 PMT Detection.....................................................90

2.10 Adjustment of the PMT Protection Window.................91

2.11 Atrial Upper Rate.........................................................92

2.12 Preventive Overdrive Pacing (Overdrive Mode) .........92

2.13 AES Detection and Pacing..........................................94

2.13.1 AES Detection .....................................................94

2.13.2 Post AES Stimulation ..........................................95

2.14 Parameters for Rate-Adaptive Pacing ........................95

2.14.1 Rate-Adaptation...................................................95

2.14.2 Sensor Gain.........................................................96

2.14.3 Automatic Sensor Gain .......................................96

2.14.4 Sensor Threshold................................................97

2.14.5 Rate Increase ......................................................97

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Stratos LV/LV-T Technical Manual iii

2.14.6 Maximum Activity Rate........................................98

2.14.7 Rate Decay..........................................................98

2.15 Sensor Stimulation ......................................................98

2.16 Rate Fading.................................................................99

2.17 Home Monitoring (Stratos LV-T)................................100

2.17.1 Transmission of Information..............................102

2.17.2 Patient Device ...................................................103

2.17.3 Transmitting Data..............................................103

2.17.4 Types of Report Transmissions ........................105

2.17.5 Description of Transmitted Data........................107

2.18 Statistics ....................................................................109

2.18.1 Timing................................................................109

2.18.2 Arrhythmia .........................................................109

2.18.3 Sensor ...............................................................109

2.18.4 Sensing..............................................................109

2.18.5 Pacing................................................................109

2.18.6 General Statistical Information ..........................110

2.19 Interrogating and/or Starting Statistics ......................110

2.20 Timing Statistics ........................................................ 111

2.20.1 Event Counter....................................................111

2.20.2 Event Episodes..................................................111

2.20.3 Rate Trend.........................................................112

2.20.4 Atrial and Ventricular Rate Histogram...............112

2.21 Arrhythmia Statistics..................................................113

2.21.1 Tachy Episode Trend ........................................113

2.21.2 AF Classification................................................113

2.21.3 AES Statistics....................................................114

2.21.4 VES Statistics....................................................115

2.22 Sensor Statistics........................................................116

2.22.1 Sensor Rate Histogram.....................................116

2.22.2 Activity Report ...................................................117

2.22.3 Sensor Optimization..........................................117

2.23 Sensing Statistics ......................................................117

2.24 Pacing Statistics ........................................................118

3. Follow-up Procedures..................................................119

3.1 General Considerations ............................................119

4. Real-Time IEGM ............................................................121

4.1 IEGM Recordings......................................................121

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iv Stratos LV/LV-T Technical Manual

5. Battery, Pulse and Lead Data ......................................123

5.1 Threshold Test - Testing the Pacing Function...........123

5.2 P/R Measurement - Testing the Sensing Function....124

5.3 Testing for Retrograde Conduction ...........................125

5.4 Non-Invasive Programmed Stimulation (NIPS).........125

5.4.1 Description.........................................................125

5.4.2 Burst Stimulation ...............................................126

5.4.3 Programmed Stimulation...................................126

5.4.4 Back up Pacing..................................................126

5.4.5 NIPS Safety Features........................................127

6. Other Functions/Features............................................129

6.1 Temporary Programming...........................................129

6.2 Patient Data Memory.................................................130

6.3 Safe Program Settings..............................................130

6.4 Magnet Effect ............................................................131

6.5 Position Indicator.......................................................131

6.6 Pacing When Exposed to Interference .....................132

7. Product Storage and Handling....................................135

7.1 Sterilization and Storage ...........................................135

7.2 Opening the Sterile Container...................................136

7.3 Pulse Generator Orientation .....................................138

8. Lead Connection ..........................................................139

8.1 Lead Configuration....................................................139

8.2 Lead Connection .......................................................140

9. Elective Replacement Indication (ERI).......................145

10. Explantation ..................................................................149

11. Technical Data...............................................................151

11.1 Available Pacing Modes............................................151

11.2 Pulse- and Control Parameters.................................151

11.3 Diagnostic Memory Functions...................................156

11.4 Home Monitoring (Stratos LV-T)................................156

11.5 Additional Functions..................................................157

11.6 Programmers.............................................................158

11.7 Default Programs ......................................................159

11.8 Materials in Contact with Human Tissue...................159

11.9 Electrical Data/Battery...............................................159

11.10 Mechanical Data ..................................................160

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Stratos LV/LV-T Technical Manual v

12. Order Information.........................................................161

Appendix A ..........................................................................163

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vi Stratos LV/LV-T Technical Manual

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Stratos LV/LV-T Technical Manual 1

1. General

1.1

Device Description

The Stratos LV and Stratos LV-T CRT-Ps are rate adaptive

pacemakers designed to provide Cardiac Resynchronization

Therapy (CRT). The Stratos CRT-Ps provide all standard

bradycardia pacemaker therapy with the additional capabilities of

biventricular pacing for CRT.

Biventricular pacing in the

Stratos CRT-Ps can be programmed to initially pace in either the

right or left ventricular chambers with separately programmable

outputs for both left and right channels. Sensing of cardiac

signals only occurs in the right ventricular chamber.

The Stratos CRT-Ps can also provide single and dual chamber

pacing in a variety of rate-adaptive and non-rate adaptive pacing

modes.

diagnostic set.

Pacing capability is supported by an extensive

For motion-based rate-adaptation, the

Stratos CRT-Ps are equipped with an internal accelerometer.

This sensor produces an electric signal during physical activity of

the patient. If a rate-adaptive (R) mode is programmed, then the

accelerometer sensor signal controls the stimulation rate.

The Stratos LV-T additionally also employs BIOTRONIK’s Home

Monitoring™ technology, which is an automatic, wireless, remote

monitoring system for management of patients with implantable

devices. With Home Monitoring, physicians can review data

about the patient’s cardiac status and CRT-P’s functionality

between regular follow-up visits, allowing the physician to

optimize the therapy process.

Stratos CRT-Ps are also

designed to collect diagnostic data to aid the physician’s

assessment of a patient’s condition and the performance of the

implanted device.

The bipolar IS-1 connections are used for pacing and sensing

(right atrial and ventricle) and the additional IS-1 connection is

used for pacing in the left ventricle in either a bipolar or unipolar

configuration depending on the left ventricular lead. The pulse

amplitude and pulse width of each of the three channels is

separately programmable.

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2 Stratos LV/LV-T Technical Manual

Stratos CRT-Ps are designed to meet all indications for Cardiac

Resynchronization Therapy in CHF patients as well as those for

bradycardia therapy as exhibited in a wide variety of patients.

The Stratos family is comprised of two CRT-Ps that are designed

to handle a multitude of situations.

Triple chamber, rate-adaptive,

Stratos LV

unipolar/bipolar pacing CRT-P

Triple chamber, rate-adaptive,

unipolar/bipolar pacing CRT-P with Home

Monitoring

Stratos LV-T

Throughout this manual, specific feature and function

descriptions may only be applicable to the Stratos LV-T and

those features will be referenced as such. Otherwise, reference

to Stratos CRT-Ps refers to both devices.

1.2

Indications

The Stratos LV and Stratos LV-T Cardiac Resynchronization

Therapy Pacemakers (CRT-Ps) are indicated for patients who

have moderate to severe heart failure (NYHA Class III/IV),

including left ventricular dysfunction (EF

≤

35%) and

QRS ≥ 120 ms and remain symptomatic despite stable, optimal

heart failure drug therapy.

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Stratos LV/LV-T Technical Manual 3

1.3

Contraindications

Use of Stratos LV and Stratos LV-T CRT-Ps are contraindicated

for the following patients:

•

Unipolar pacing is contraindicated for patients with an

implanted cardioverter-defibrillator (ICD) because it may

cause unwanted delivery or inhibition of ICD therapy.

•

Single chamber atrial pacing is contraindicated for

patients with impaired AV nodal conduction.

Dual chamber and single chamber atrial pacing is

contraindicated for patients with chronic refractory atrial

tachyarrhythmias.

1.4

Note to Physician

As with any implantable pulse generator, there are certain

infrequent risks associated with Stratos CRT-Ps. Section 1.6

lists the adverse events that have been observed or may

potentially occur with these Cardiac Resynchronization Therapy

Pacemakers.

The warnings and precautions listed in

Section 1.5 should be taken under serious consideration in order

to aid in avoiding device failures and harm to the patient.

Regular monitoring of the patient and their implanted device

should be conducted to identify performance concerns and

ensure appropriate therapy is being administered to the patient.

Please communicate any performance concerns to BIOTRONIK

and to FDA.

All explanted devices should be returned to the manufacturer for

testing to help understand device reliability and performance.

Refer to Section 10 for recommended procedures for handling

explanted devices.

1.5

Warnings and Precautions

Certain therapeutic and diagnostic procedures may cause

undetected damage to a Cardiac Resynchronization Therapy

Pacemakers, resulting in malfunction or failure at a later time.

Please note the following warnings and precautions:

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4 Stratos LV/LV-T Technical Manual

Magnetic Resonance Imaging (MRI) – Avoid use of magnetic

resonance imaging as it has been shown to cause movement of

the CRT-Ps within the subcutaneous pocket and may cause pain

and injury to the patient and damage to the CRT-P. If the

procedure must be used, constant monitoring is recommended,

including monitoring the peripheral pulse.

Rate Adaptive Pacing – Use rate adaptive pacing with care in

patients unable to tolerate increased pacing rates.

NIPS – Life threatening ventricular arrhythmias can be induced

by stimulation in the ventricle. Ensure that an external cardiac

defibrillator is accessible during tachycardia testing. Only

physicians trained and experienced in tachycardia induction and

reversion protocols should use non-invasive programmed

stimulation (NIPS).

High Output Settings – High output settings combined with

extremely low lead impedance may reduce the life expectancy of

the Stratos CRT-Ps. Programming of pulse amplitudes, higher

than 4.8 V, in combination with long pulse widths and/or high

pacing rates may lead to premature activation of the

replacement indicator.

1.5.1 Interactions with Other Medical Therapy

Before applying one of the following procedures, a detailed

analysis of the advantages and risks should be made. Cardiac

activity during one of these procedures should be confirmed by

continuous monitoring of peripheral pulse or blood pressure.

Following the procedures, CRT-P function and stimulation

threshold must be checked.

Therapeutic Diathermy Equipment – Use of therapeutic

diathermy equipment is to be avoided for pacemaker patients

due to possible heating effects of the CRT-P and at the implant

site. If diathermy therapy must be used, it should not be applied

in the immediate vicinity of the CRT-P or leads. The patient's

peripheral pulse should be monitored continuously during the

treatment.

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Stratos LV/LV-T Technical Manual 5

Transcutaneous Electrical Nerve Stimulation (TENS) –

Transcutaneous electrical nerve stimulation may interfere with

CRT-P function. If necessary, the following measures may

reduce the possibility of interference:

•

Place the TENS electrodes as close to each other as

possible.

Place the TENS electrodes as far from the CRT-P/lead

system as possible.

Monitor cardiac activity during TENS use.

Defibrillation – The following precautions are recommended to

minimize the inherent risk of CRT-P operation being adversely

affected by defibrillation:

•

The paddles should be placed anterior-posterior or along

a line perpendicular to the axis formed by the CRT-P

and the implanted lead.

•

The energy setting should not be higher than required to

achieve defibrillation.

The distance between the paddles and the CRT-P/leads

should not be less than 10 cm (4 inches).

Radiation – The CRT-P’s internal electronics may be damaged

by exposure to radiation during radiotherapy. To minimize this

risk when using such therapy, the CRT-P should be protected

with local radiation shielding.

Lithotripsy – Lithotripsy treatment should be avoided for CRT-P

patients since electrical and/or mechanical interference with the

CRT-P is possible. If this procedure must be used, the greatest

possible distance from the point of electrical and mechanical

strain should be chosen in order to minimize a potential

interference with the CRT-P.

Electrocautery – Electrocautery should never be performed

within 15 cm (6 inches) of an implanted CRT-P or leads because

of the danger of introducing fibrillatory currents into the heart

and/or damaging the CRT-P. Pacing should be asynchronous

and above the patient’s intrinsic rate to prevent inhibition by

interference signals generated by the cautery. When possible, a

bipolar electrocautery system should be used.

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6 Stratos LV/LV-T Technical Manual

For transurethral resection of the prostate, it is recommended

that the cautery ground plate be placed under the buttocks or

around the thigh, but not in the thoracic area where the current

pathway could pass through or near the CRT-P system.

1.5.2 Storage and Sterilization

Storage (temperature) – Recommended storage temperature

range is 5° to 55°C (41°-131°F). Exposure to temperatures

outside this range may result in CRT-P malfunction (see

Section 7.1).

Low Temperatures – Exposure to low temperatures (below

0°C) may cause a false elective replacement indication to be

present. If this occurs, warm the device to room temperature

and reset the ERI with magnet application (see Section 7.1).

Handling – Do not drop. If an unpackaged CRT-P is dropped

onto a hard surface, return it to BIOTRONIK (see Section 7.1).

FOR SINGLE USE ONLY - Do not re-sterilize the CRT-P or

accessories packaged with the CRT-P, they are intended for

one-time use.

Device Packaging – Do not use the device if the packaging is

wet, punctured, opened or damaged because the integrity of the

sterile packaging may be compromised. Return the device to

BIOTRONIK.

Storage (magnets) – Store the device in a clean area, away

from magnets, kits containing magnets, and sources of

electromagnetic interference (EMI) to avoid damage to the

device.

Temperature Stabilization – Allow the device to reach room

temperature before programming or implanting the device.

Temperature extremes may affect the initial device function.

Use Before Date – Do not implant the device after the USE

BEFORE DATE because the device may have reduced

longevity.

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Stratos LV/LV-T Technical Manual 7

1.5.3 Lead Connection and Evaluation

Lead Check –

Feature Description: Lead Check is a feature that, when

activated, automatically measures the lead impedance with

every pace.

Based on these measurements, the lead

configuration will be set to either unipolar or bipolar. Refer to

Section 2.5 for more details regarding this feature.

Caution: Lead check will not lead to disabling of cardiac

resynchronization therapy. It limits the use of the

resynchronization features.

1. Lead check is possible only when the right ventricle is

paced first.

2. Lead check works only when the pacing voltages are

programmed between 2.4 and 4.8 V. The lead check

feature can be programmed OFF in patients that require

cardiac resynchronization therapy.

Care should be taken when programming Stratos CRT-Ps with

Lead Check ON as the device may switch from bipolar to

unipolar pacing and sensing without warning. This situation may

be inappropriate when using a Stratos CRT-P for patients with

an Implantable Cardioverter Defibrillator (ICD). The following

associated message appears when programming this feature:

“Lead check may result in a switch to unipolar pacing and

sensing, which may be inappropriate for patients with an

ICD.”

Additionally, Lead Check should be programmed OFF before

lead connection as the feature will automatically reprogram the

device to unipolar in the absence of a lead.

Lead / CRT-P Compatibility – Because of the numerous

available 3.2-mm configurations (e.g., the IS-1 and VS-1

standards), lead/ CRT-P compatibility should be confirmed with

the CRT-P and/or lead manufacturer prior to the implantation of

the system.

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8 Stratos LV/LV-T Technical Manual

IS-1, wherever stated in this manual, refers to the international

standard, whereby leads and generators from different

manufacturers are assured a basic fit. [Reference ISO 5841-

3:1992(E)].

Lead Configuration – The polarity of the implanted lead

dictates what lead configuration can be programmed for the

CRT-P. Pacing will not occur with a unipolar lead if the lead

configuration of the respective channel is programmed to bipolar

(see Section 8).

Setscrew Adjustment – Back-off the setscrew(s) prior to

insertion of lead connector(s) as failure to do so may result in

damage to the lead(s), and/or difficulty connecting lead(s).

Cross Threading Setscrew(s) – To prevent cross threading

the setscrew(s), do not back the setscrew(s) completely out of

the threaded hole. Leave the torque wrench in the slot of the

setscrew(s) while the lead is inserted.

Tightening Setscrew(s) – Do not overtighten the setscrew(s).

Use only the BIOTRONIK supplied torque wrench.

Sealing System – Be sure to properly insert the torque

wrench into the perforation at an angle perpendicular to the

connector receptacle. Failure to do so may result in damage to

the plug and its self-sealing properties.

1.5.4 Programming and Operation

IEGM – Due to the compression processes that the signals

undergo, the IEGM recordings are not suitable for making some

specific cardiac diagnoses, such as ischemia; although, these

tracings may be useful in diagnosing arrhythmias, device

behavior or programming issues.

Post AES - Before activating post-AES, check whether the

selected program can cause Pacemaker Mediated Tachycardia

(PMT) and whether post-AES pacing results.

Overdrive Pacing Mode - When programming the overdrive

pacing mode, check whether the selected program can cause

PMT, and whether atrial over drive pacing would result.

Corresponding to the measured retrograde conduction time, the

PMT protection interval must be programmed to a correct value.

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Stratos LV/LV-T Technical Manual 9

AV Hysteresis – If the AV hysteresis is enabled along with the

algorithm for recognizing and terminating PMTs (PMT

management), the AV delay for recognizing and terminating a

PMT has a higher priority than the AV hysteresis.

Sensing – The Stratos CRT-Ps do not sense in the left ventricle.

AV Conduction – In patients with intact AV conduction, the

intrinsic atrial tachycardia is conducted to the ventricle 1:1. With

the resynchronization mode activated, spontaneous rate of the

right ventricle mode is synchronized for a rate up to 200 ppm in

the left ventricle. For this reason, biventricular pacing mode

should be turned OFF in such cases.

Unipolar/Bipolar – If the pacing or sensing function is to be

programmed to bipolar in the atrial channel, it must be verified

that bipolar leads have been implanted in that chamber. If the

atrial lead is unipolar, unipolar sensing and pacing functions

must be programmed in that chamber. Failure to program the

appropriate lead configuration could result in patient

experiencing entrance and/or exit block.

In addition, if the atrial lead polarity setting within the Patient

Data Memory has been set to bipolar, the polarity of the

corresponding implanted lead must be confirmed to be bipolar.

Safe Program – Activating the “Safe Program” is a way of

quickly programming the device to multiple settings in the event

of an emergency. These settings include unipolar pacing with

pacing output OFF in the left ventricular channel. Refer to

Section 6.3 for further details.

Programmers – Use only BIOTRONIK’s ICS 3000 programmer

equipped with appropriate software to program Stratos CRT-Ps.

Do not use programmers from other manufacturers.

Pulse Amplitude – Programming of pulse amplitudes, higher

than 4.8 V, in combination with long pulse widths and/or high

pacing rates can lead to premature activation of the replacement

indicator. If a pulse amplitude of 7.2 V or higher is programmed

and high pacing rates are reached, output amplitudes may differ

from programmed values.

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10 Stratos LV/LV-T Technical Manual

Pacing thresholds – When decreasing programmed output

(pulse amplitude and/or pulse width), the pacing threshold must

first be accurately assessed to provide a 2:1 safety margin.

EMI – Computerized systems are subject to (Electromagnetic

Interference (EMI) or “noise”.

In the presence of such

interference, telemetry communication may be interrupted and

prevent programming of the Stratos CRT-P.

Programming Modifications – Extreme programming changes

should only be made after careful clinical assessment. Clinical

judgment should be used when programming permanent pacing

rates below 40 ppm or above 100 ppm.

Short Pacing Intervals – Use of short pacing intervals (high

pacing rates) with long atrial and/or ventricular refractory periods

may result in intermittent asynchronous pacing and, therefore,

may be contraindicated in some patients.

OFF Mode – The OFF mode can be transmitted as a temporary

program only to permit evaluation of the patient’s spontaneous

rhythm. (see Section 2.1.11)

Myopotential Sensing

–

The filter characteristics of

BIOTRONIK implantable devices have been optimized to sense

electrical potentials generated by cardiac activity and to reduce

the possibility of sensing skeletal myopotentials. However, the

risk of CRT-P’s operation being affected by myopotentials

cannot be eliminated, particularly in unipolar systems.

Myopotentials may resemble cardiac activity, resulting in

inhibition of pacing, triggering and/or emission of asynchronous

pacing pulses, depending on the pacing mode and the

interference pattern. Certain follow-up procedures, such as

monitoring CRT-P performance while the patient is doing

exercises involving the use of pectoral muscles, as well as Holter

monitoring, have been recommended to check for interference

caused by myopotentials.

If sensing of myopotentials is

encountered, corrective actions may include selection of a

different pacing mode or sensitivity setting.

Muscle or Nerve Stimulation – Inappropriate muscle or nerve

stimulation may occur with unipolar pacing when using a non-

coated Stratos CRT-P.

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Stratos LV/LV-T Technical Manual 11

Atrial Sensitivity – In dual chamber systems, the atrial

sensitivity of 0.1 mV should only be programmed in conjunction

with a bipolar lead configuration.

Programmed to Triggered Modes – When programmed to

triggered modes, pacing rates up to the programmed upper limit

may occur in the presence of either muscle or external

interference.

Triggered Modes – While the triggered modes (DDT, DVT,

DDTR/A, DDTR/V, DDI/T, VDT, VVT, and AAT) can be

programmed permanently, these modes are intended for use as

temporary programming for diagnostic purposes. In triggered

pacing modes, pacing pulses are emitted in response to sensed

signals, and therefore the pacing pulse can be used as an

indicator, or marker of sensed events for evaluating the sensing

function of the pulse generator using surface ECG. However,

real-time telemetry of marker channels and/or intracardiac

electrogram via the programmer and programming wand is

recommended over the use of a triggered pacing mode in the

clinical setting. A triggered pacing mode may be preferred in

situations where positioning the programming head over the

pulse generator would be impossible or impractical (i.e., during

exercise testing or extended Holter monitoring).

Another possible application of triggered modes is to ensure

pacing as a short term solution during a period of inhibition of

pacing by extracardiac interference, mechanical noise signals, or

other sensing abnormalities. Because triggered modes emit

pacing pulses in response to sensed events, this may result in

unnecessary pacing during the absolute refractory period of the

myocardium, inappropriate pacing in response to oversensing of

cardiac or extracardiac signals. The risks associated with

triggered pacing include excessive pacing, arrhythmias due to

the R-on-T phenomenon, and early battery depletion. Therefore,

it is important that the triggered modes are not used for long

term therapy, and that the CRT-P is always returned to a non-

triggered permanent program.

1.5.5 Home Monitoring

Patient’s Ability - Use of the Home Monitoring system requires

the patient and/or caregiver to follow the system instructions and

cooperate fully when transmitting data.

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12 Stratos LV/LV-T Technical Manual

If the patient cannot understand or follow the instructions

because of physical or mental challenges, another adult who can

follow the instructions will be necessary for proper transmission.

Electromagnetic Interference (EMI) – Precautions for EMI

interference with the Stratos CRT-Ps are provided in

Section 1.5.6. Sources of EMI including cellular telephones,

electronic article surveillance systems, and others are discussed

therein.

Use in Cellular Phone Restricted Areas - The mobile patient

device (transmitter/receiver) should not be utilized in areas

where cellular phones are restricted or prohibited (i.e.,

commercial aircraft).

Event Triggered Report - A timely receipt of the event report

cannot be guaranteed. The receipt is also dependent on

whether the patient was physically situated in the required

coverage range of the patient device at the time the event

information was sent.

Patient-Activated Report - The magnet effect must be

programmed “synchronous” if the [Patient Report] function is

activated.

Not for Conclusive Diagnosis - Because not all information

available in the implant is being transmitted, the data transmitted

by Home Monitoring should be evaluated in conjunction with

other clinical indicators (i.e., in-office follow-up, patient

symptoms, etc.) in order to make a proper diagnosis.

Frequency of Office Follow-Ups When Using Home

Monitoring - The use of Home Monitoring does not replace

regular follow-up examinations. When using Home Monitoring,

the time period between follow-up visits may not be extended.

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Stratos LV/LV-T Technical Manual 13

1.5.6 Electromagnetic Interference (EMI)

The operation of any implanted device may be affected by

certain environmental sources generating signals that resemble

cardiac activity. This may result in inhibition of pacing and/or

triggering or in asynchronous pacing depending on the pacing

mode and the interference pattern. In some cases (i.e.,

diagnostic or therapeutic medical procedures), the interference

sources may couple sufficient energy into a pacing system to

damage the device and/or cardiac tissue adjacent to the leads.

BIOTRONIK CRT-Ps have been designed to significantly reduce

susceptibility to electromagnetic interference (EMI). However,

due to the variety and complexity of sources creating

interference, there is no absolute protection against EMI.

Generally, it is assumed that EMI produces only minor effects, if

any, in CRT-P patients. If the patient may be exposed to one of

the following environmental conditions, then the patient should

be given the appropriate warnings.

1.5.7 Home and Occupational Environments

The following equipment (and similar devices) may affect normal

CRT-P operation: electric arc welders, electric melting furnaces,

radio/television and radar transmitters, power-generating

facilities, high-voltage transmission lines, electrical ignition

systems (also of gasoline-powered devices) if protective hoods,

shrouds, etc., are removed, electrical tools, anti-theft devices at

retail stores and electrical appliances, if not in proper condition

or not correctly grounded and encased.

Patients should exercise reasonable caution in avoidance of

devices which generate a strong electric or magnetic field. If

EMI inhibits pacing or causes a reversion to asynchronous

pacing or pacing at magnet rate, moving away from the source

or turning it off should allow the CRT-P to return to its normal

mode of operation. Some potential EMI sources include:

High Voltage Power Transmission Lines – High voltage power

transmission lines may generate enough EMI to interfere with

CRT-P operation if approached too closely.

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14 Stratos LV/LV-T Technical Manual

Home Appliances – Home appliances normally do not affect

CRT-P operation if the appliances are in proper condition and

correctly grounded and encased. There are reports of CRT-P

disturbances caused by electrical tools and by electric razors

that have touched the skin directly over the CRT-P.

Communication Equipment – Communication equipment such

as microwave transmitters, linear power amplifiers, or high-

power amateur transmitters may generate enough EMI to

interfere with CRT-P operation if approached too closely.

Commercial Electrical Equipment – Commercial electrical

equipment such as arc welders, induction furnaces, or

resistance welders may generate enough EMI to interfere with

CRT-P operation if approached too closely.

Electrical Appliances – Electric hand-tools and electric razors

(used over the skin directly above the CRT-P) have been

reported to cause pacemaker disturbances. Home appliances

that are in good working order and properly grounded do not

usually produce enough EMI to interfere with implanted device

operation.

Electronic Article Surveillance (EAS) – Equipment such as

retail theft prevention systems may interact with the CRT-Ps.

Patients should be advised to walk directly through and not to

remain near an EAS system longer than necessary.

Radio-Frequency Identification (RFID) – RFID tags may

interact with the CRT-Ps. Patients should be advised to avoid

leaving a device containing such a tag within close proximity to

the CRT-P (i.e., inside a shirt pocket).

1.5.8 Cellular Phones

Recent studies have indicated there may be a potential

interaction between cellular phones and pacemaker operation.

Potential effects may be due to either the radio frequency signal

or the magnet within the phone and could include inhibition or

asynchronous pacing when the phone is within close proximity

(within 6 inches [15 cm]) to the CRT-P.

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Stratos LV/LV-T Technical Manual 15

Based on testing to date, effects resulting from an interaction

between cellular phones and the implanted pacemakers have

been temporary. Simply moving the phone away from the

implanted device will return it to its previous state of operation.

Because of the great variety of cellular phones and the wide

variance in patient physiology, an absolute recommendation to

cover all patients cannot be made.

Patients having an implanted CRT-P who operate a cellular

phone should:

•

Maintain a minimum separation of 6 inches (15 cm)

between a hand-held personal cellular phone and the

implanted device. Portable and mobile cellular phones

generally transmit at higher power levels compared to

hand held models. For phones transmitting above

3 watts, maintain a minimum separation of 12 inches

(30 cm) between the antenna and the implanted device.

•

Patients should hold the phone to the ear opposite the

side of the implanted device. Patients should not carry

the phone in a breast pocket or on a belt over or within

6 inches (15 cm) of the implanted device as some

phones emit signals when they are turned ON but not in

use (i.e., in the listen or standby mode). Store the

phone in a location opposite the side of implant.

1.5.9 Hospital and Medical Environments

Refer to Section 1.5.1 for information regarding CRT-P

interaction with the following medical procedures / environments:

•

Electrosurgical Cautery

Lithotripsy

External Defibrillation

High Radiation Sources

1.5.10 Device Explant and Disposal

Device Incineration - Never incinerate a CRT-P. Be sure the

CRT-P is explanted before a patient who has died is cremated.

(see Section 10)

Explanted Devices

–

Return all explanted devices to

BIOTRONIK.

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16 Stratos LV/LV-T Technical Manual

1.6

Potential Effects of the Device on

Health

The following possible adverse events may occur with this type

of CRT-P based on implant experience including:

Potential Adverse Events

•

Air embolism

•

Lead-related

thrombosis

Allergic reactions to

contrast media

Arrhythmias

Bleeding

Body rejection

phenomena

Cardiac tamponade

Chronic nerve damage

Damage to heart valves

Elevated pacing

thresholds

Extrusion

Fluid accumulation

Infection

Local tissue reaction /

fibrotic tissue formation

Muscle or nerve

stimulation

Myocardial damage

Myopotential sensing

Pacemaker mediated

tachycardia

Pneumothorax

Pocket erosion

Hematoma

Device migration

Thromboembolism

Undersensing of

intrinsic signals

Venous occlusion

Venous or cardiac

perforation

•

Keloid formation

Lead dislodgment

Lead fracture / insulation

damage

•

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Stratos LV/LV-T Technical Manual 17

1.7

Clinical Studies

The subsequent sections summarize the following three clinical

studies that were used to support the safety and effectiveness of

the Stratos LV/LV-T CRT-Ps.

•

The AVAIL CLS/CRT clinical study

The OVID clinical study (OUS)

The OPTION CRT/ATx clinical study

Two of the studies, AVAIL CLS/CRT and OVID, collected

significant safety data supporting use of the Stratos LV/LV-T

CRT-P system. The third study, OPTION CRT/ATx, supports

the effectiveness of cardiac resynchronization therapy (CRT).

The OPTION CRT/ATx study was conducted on a device that

delivers CRT but, in addition, also offers defibrillation therapy

(CRT-D).

1.7.1 Stratos LV Clinical Study – AVAIL CLS/CRT

Study Design

The AVAIL CLS/CRT was

multi-center, prospective,

randomized, blinded clinical study designed to support approval

for cardiac resynchronization therapy for a Heart Failure (HF)

patient population not requiring back up defibrillation and that are

indicated for an ablate and pace procedures. All patients

enrolled into the clinical study were randomly assigned to one of

three groups using a 2:2:1 ratio for randomization.

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18 Stratos LV/LV-T Technical Manual

•

Patients assigned to Group 1 received biventricular

pacing with CLS-based rate adaptive pacing using

BIOTRONIK’s Protos DR/CLS, which is a dual-chamber

pulse generator with CLS-based rate adaptive pacing.

During this study, the Protos DR/CLS devices were

implanted with two ventricular leads: the right ventricular

lead was connected to the ventricular port, and the left

ventricular lead was connected to the atrial port. Protos

DR/CLS was included in this study to evaluate

biventricular pacing with a different type of rate adaptive

sensor technology.

•

Patients assigned to Group 2 received biventricular

pacing with accelerometer-based rate adaptive pacing

using the Stratos LV.

Patients assigned to Group 3 (control group) received

right ventricular pacing with accelerometer-based rate

adaptive pacing using the Stratos LV. Therefore, 60% of

the patients received a Stratos LV device.

Primarily, the study evaluated and compared the functional

benefits of CRT between the three randomized groups using a

composite endpoint consisting of a six-minute walk test (meters

walked) and quality of life measurement (assessed using the

Minnesota Living with Heart Failure Questionnaire). Relevant

measurements were completed twice for each patient: once at

the Baseline evaluation (prior to implant and ablation) and again

at a six-month follow-up evaluation. The data collected during

this clinical study was used to demonstrate superiority of CRT to

RV only pacing. This study also evaluated the safety of both the

Protos DR/CLS and Stratos LV devices through an analysis of

the complication-free rate through six months. Secondarily, the

study also evaluated the superiority of CRT with CLS rate

adaptation compared to CRT with accelerometer rate adaptation.

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Stratos LV/LV-T Technical Manual 19

Clinical Inclusion Criteria

To support the objectives of this investigation, patients were

required to meet the following inclusion criteria prior to

enrollment:

•

Meet the indications for therapy

Persistent (documented for more than

days),

symptomatic AF with poorly controlled rapid ventricular

rates or permanent, (documented for more than 30 days

with failed cardioversion, or longstanding AF of 6 months

or more) symptomatic AF with poorly controlled rapid

ventricular rates.

•

Eligible for AV nodal ablation and permanent pacemaker

implantation

•

NYHA Class II or III heart failure

Age ≥ 18 years

Understand the nature of the procedure

Ability to tolerate the surgical procedure required for

implantation

•

Give informed consent

Able to complete all testing required by the clinical

protocol

•

Available for follow-up visits on a regular basis at the

investigational site

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20 Stratos LV/LV-T Technical Manual

Clinical Exclusion Criteria

To support the objectives of this investigation, the exclusion

criteria at the time of patient enrollment included the following:

•

Meet one or more of the contraindications

Have a life expectancy of less than six months

Expected to receive heart transplantation within six

months

•

Enrolled in another cardiovascular or pharmacological

clinical investigation

•

Patients with an ICD, or being considered for an ICD

Patients with previously implanted biventricular pacing

systems

•

Patients with previously implanted single or dual

chamber pacing system with

ventricular pacing

> 50% documented

•

Patients with previous AV node ablation

Six-minute walk test distance greater than 450 meters

Any condition preventing the patient from being able to

perform required testing

•

Presence of another life-threatening, underlying illness

separate from their cardiac disorder

Conditions that prohibit placement of any of the lead

systems

Follow-Up Schedule

At the enrollment screening, the physician evaluated the patient

to verify that all inclusion/exclusion criteria have been met in

accordance to the protocol and the patient has signed the

informed consent. After successful enrollment, all patients were

implanted with either a Stratos LV CRT-P or Protos DR/CLS

device. Evaluations at the Four Week, Three and Six Month

follow-ups included NYHA classification, medications, and

percentage of ventricular pacing.

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Stratos LV/LV-T Technical Manual 21

Clinical Endpoints

Primary Endpoint: Complication-free Rate (Safety)

The safety of the Stratos LV was evaluated based on

complications (adverse events that require additional invasive

intervention to resolve) related to the implanted CRT system

which includes the Stratos LV, the right ventricular, the left

ventricular lead, lead ventricular lead adapters (if used) and the

implant procedure. The target complication-free rate at six

months is 85%.

Primary Endpoint: Six Minute Walk Test & QOL (Effectiveness)

The purpose of Primary Endpoint 1 was to evaluate the

effectiveness of the CRT (Groups 1 and 2) compared to RV only

(Group 3) pacing as measured by the average composite rate of

improvement in six minute walk test and QOL.

Accountability of PMA Cohorts

After randomization and enrollment, 23 patients (8 in Group 1, 8

in Group 2 and 7 in Group 3) did not receive an implant. The

reasons for patients not receiving an implant are outlined in

Figure 1.

Two additional patients in Group 1 had an

unsuccessful first implant attempt (unable to implant the LV

lead), but follow up data was not received.

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22 Stratos LV/LV-T Technical Manual

No implant Attempted

Enrolled and Randomized Patients

Withdrawal of Consent

Group 1

Group 2

Group 3

Group 1

Group 2

Group 3

Not Meeting Inclusion Criteria

Group 1

Group 2

Group 3

Unsuccessful implant

Withdrawal of IC before 2nd Attempt

Implant Attempted

Group 1

Group 2

Group 3

Group 2

Group 3

Follow-up to failed implant data pending

Group 1

Group 2

Group 3

Ablation/Ablation Data Pending

Group 1

Group 2

Group 3

Successful implant

Group 1

Group 2

Group 3

6-Month Follow-up Data

Patient Death before 6-Month

Group 1

Group 2

Group 3

Withdrew before 6-Month FU

Group 1

Group 2

Group 3

Not Reached 6-Month FU or Data Pending

Group 1

Group 2

Group 3

Completed 6-Month Follow-up

Group 1

Group 2

Group 3

6-month FU Not Completed

Group 1

Group 2

Group 3

Figure 1: Patient Accountability

Demographics and Baseline Parameters

Table 1 provides a summary of the patient demographics at

enrollment. There were no statistical differences in enrollment

demographics between the 3 groups.

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Stratos LV/LV-T Technical Manual 23

Table 1: Patient Demographics at Enrollment

P-value

Characteristic

Group1

Group 2

Group 3

Age @

N=25

71.5 ± 1.6

52 to 85

N=42

73.7 ± 1.3

56 to 90

N=50

72.3 ± 1.2

51 to 86

Enrollment (Yrs)

Mean ± SE

Range

0.534*

N=42

N=50

N=25

Gender

Male

Female

18 (42.9%) 19 (38.0%) 13 (52.0%) 0.553**

24 (57.1%) 31 (62.0%) 12 (48.0%)

Six-Minute Walk

Distance

(meters)

Mean ± SE

Range

N=42

262.7 ±

15.1

N=50

283.6 ±

13.8

N=25

267.8 ±

22.9

0.395*

78 to 420

37 to 438

23 to 420

New York Heart

Association

Class

Class II

Class III

N=25

10 (40.0%)

15 (60.0%)

N=42

N=50

0.189**

23 (54.8%) 18 (36.0%)

19 (45.2%) 32 (64.0%)

Underlying Heart

Disease

Dilated

Cardiomyopathy

Hypertrophic

Cardiomyopathy

Valvular Heart

Disease

Coronary Artery

Disease

Hypertension

No underlying

structural heart

disease

N=25

1 (4.0%)

N=42

8 (19.0%)

N=49

11 (22.4%)

0.125**

0.216**

2 (8.0%)

4 (9.5%)

1 (2.0%)

5 (20.0%) 0.792**

6 (24.0%) 0.031**

12 (28.6%) 12 (24.5%)

19 (45.2%) 28 (57.7%)

37 (88.1%) 37 (75.5%)

19 (76.0%) 0.348**

7 (28.0%) 0.007**

3 (7.1%)

2 (4.1%)

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24 Stratos LV/LV-T Technical Manual

Table 1: Patient Demographics at Enrollment

P-value

Characteristic

Group1

Group 2

Group 3

Other Medical

History

Diabetes

Chronic Lung

Disease

N=29

13 (44.8%)

7 (24.1%)

N=36

9 (25.0%)

16 (44.4%)

N=17

4 (23.5%) 0.287**

7 (41.2%) 0.211**

12 (41.4%) 12 (33.3%)

5 (29.4%) 0.791**

Thyroid Disease

Chronic Kidney

Disease

Prior Ischemic

Stroke or TIA

Prior Embolic

Events (non-

cerebrovascular)

4 (13.8%)

7 (24.1%)

1 (2.3%)

5 (13.9%)

10 (27.8%)

3 (6.0%)

1 (5.9%)

6 (35.3%) 0.726**

2 (8.0%) 0.653**

0.836**

*One-way ANOVA, ** Chi-Square test (2-sided)

Table 2 provides a summary of the AF medical history. Table 3

provides a summary of cardiac medications patients were taking

at the time of enrollment. Please note some categories may

equal more than 100% as several categories allow more than

one response. In some cases, complete demographic data was

not provided for all patients.

There were no statistical

differences in AF medical history and cardiac medication at

enrollment between the 3 groups.

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Stratos LV/LV-T Technical Manual 25

Table 2: Atrial Fibrillation Demographics at Enrollment

Characteristic

Group 1

Group 2

Group 3 P-value*

Classification of

Atrial Fibrillation

Persistent AF

N=42

N=50

N=24

6 (25%)

18 (75%)

0.537

10 (23.8%) 17 (34%)

32 (76.2%) 33 (66%)

Permanent AF

Classification of

Symptoms Related

to AF

N=42

N=49

N=25

Palpitations

Chest Pain

Dyspnea or shortness

of breath

32 (76.2%) 34 (69.4%) 14 (56.0%)

6 (14.3%) 7 (14.3%) 3 (12.0%)

36 (85.7%) 40 (81.6%) 19 (76.0%)

0.236

1.000

0.568

34 (81.0%) 45 (91.8%) 18 (72.0%)

17 (40.5%) 13 (26.5%) 9 (36.0%)

0.149

0.329

Fatigue

Lightheadedness or

syncope

9 (21.4%) 11 (22.4%) 10 (40.0%)

0.205

Other

Previous AF

Ablation

N=42

N=50

N=25

0.354

37 (88.1%) 47 (94.0%) 21 (84.0%)

Yes

5 (11.9%)

N=41

12 (29.3%) 10 (20.8%) 10 (41.7%)

17 (41.5%) 22 (45.8%) 13 (54.2%)

17 (41.5%) 23 (47.9%) 12 (50.0%)

0 (0.0%)

4 (9.8%)

5 (12.2%) 5 (10.4%)

0 (0.0%)

2 (4.9%)

9 (22.0%) 10 (20.8%) 2 (8.3%)

5 (12.2%) 8 (16.7%) 3 (12.5%)

19 (46.3%) 28 (58.3%) 10(41.7%)

0 (0.0%)

7 (17.1%) 15 (31.3%) 4 (16.7%)

5 (12.2%) 5 (10.4%) 1 (4.2%)

3 (6.0%)

4 (16.0%)

Past Medications

for Rate or Rhythm

Control

Amiodarone

Digoxin

Diltiazem

Disopyramide

Dofetilide

Flecanide

Ibutilide

Procainamide

Propafenone

Sotolol

N=48

N=24

0.192

0.683

0.804

0.228

0.895

0.656

0.215

0.506

0.423

0.389

0.829

0.382

0.215

0.248

0.656

3 (6.3%)

0 (0.0%)

2 (8.3%)

1 (4.2%)

0 (0.0%)

2 (4.2%)

4 (8.3%)

Verapamil

Metoprolol

Propranolol

Other Beta-Blockers

Other Medications

0 (0.0%)

1 (4.2%)

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26 Stratos LV/LV-T Technical Manual

Table 2: Atrial Fibrillation Demographics at Enrollment

Characteristic

Group 1

Group 2

Group 3 P-value*

Rate Control

Medication,

Reasons for

Discontinuation

Ineffective

Not tolerated

Other

N=17

N=20

N=12

10 (58.8%) 13 (65.0%) 9 (75.0%)

8 (47.1%) 7 (35.0%) 3 (25.0%)

1 (5.9%)

0.558

0.760

0.800

2 (10.0%)

0 (0.0%)

Rhythm Control

Medication,

Reasons for

Discontinuation

Ineffective

Not tolerated

Other

N=22

N=25

N=13

17 (77.3%) 20 (80.0%) 8 (61.5%)

6 (27.3%) 7 (28.0%) 6 (46.2%)

1 (4.5%)

0.759

0.530

0.430

1 (4.0%)

2 (15.4%)

Cardioversion

History

N=42

N=49

N=25

Successful prior

electrical

0.760

13 (31.0%) 16 (32.7%) 10 (40.0%)

13 (100.0%) 15 (93.8%) 10 (100.0%)

cardioversion

Transthoracic

Transvenous

Unsuccessful prior

electrical

0.808

0.680

0 (0.0%)

1 (6.3%)

0 (0.0%)

15 (35.7%) 14 (28.6%) 7 (28.0%)

cardioversion

Transthoracic

Transvenous

No electrical

cardioversion

attempted

0.741

0.936

15 (100.0%) 14 (93.3%) 7 (100.0%)

0 (0.0%)

2 (13.3%)

0 (0.0%)

17 (40.5%) 20 (40.8%) 9 (36.0%)

Successful prior

pharmacological

cardioversion

Unsuccessful prior

pharmacological

cardioversion

0.547

0.678

0.915

5 (11.9%)

3 (6.1%)

3 (12.0%)

8 (19.0%) 11 (22.4%) 7 (28.0%)

23 (54.8%) 29 (59.2%) 15 (60.0%)

No pharmacological

cardioversion

attempted

*Chi-Square test (2-sided)

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Stratos LV/LV-T Technical Manual 27

Table 3: Current Cardiac Medications at Enrollment

Group 1 Group 2

N=42 N=50

Group 3

N=25

P-

value*

Drug Category

Anti-Arrhythmics

Rate Control Medications 32 (76.2%) 43 (87.8%) 20(80.0%)

0.480

0.462

0.863

0.686

0.848

12 (28.6%) 10 (20.4%) 4 (16.0%)

Anti-thrombic Agents

Anti-Coagulants

ACE Inhibitors

17 (40.5%) 19(38.8%) 11 (44.0%)

36 (85.7%) 40 (81.6%) 22 (88.0%)

16 (38.1%) 16 (32.7%) 8 (32.0%)

Angiotensin-Receptor

Blockers

10 (23.8%) 7 (14.3%) 4 (16.0%) 0.491

0.255

0.803

0.714

0.947

0.941

Diuretics

30 (71.4%) 34 (69.4%) 13 (52.0%)

1 (2.4%) 2 (4.1%) 0 (0.0%)

Inotropes

Nitrates

3 (7.1%) 6 (12.2%) 2 (8.0%)

6 (14.3%) 9 (18.4%) 4 (16.0%)

23 (54.8%) 26 (53.1%) 14 (56.0%)

Beta-Blockers for CHF

Other

*Chi-Square test (2-sided)

Safety and Effectiveness Results

A total of 118 patients were enrolled in the AVAIL CLS/CRT

clinical study at 20 sites:

There were 43 Group 1, 50 Group 2, and 25 Group 3 patients in

this prospective, multi-center, randomized clinical study. For

Group 1, there were 33 successful implants (76.7%) of the

Protos DR/CLS system. For Groups 2 and 3, there were 44 and

21 successful implants (88.0% and 84.0%) respectively of the

Stratos LV CRT-P system.

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28 Stratos LV/LV-T Technical Manual

•

The study was designed to enroll 265 patients.

However, the study was terminated early due to slow

patient enrollment. There were no safety issues involved

in the termination decision. Due to the lack of patient

data, the AVAIL CLS/CRT study alone was insufficient to

support CRT pacing effectiveness or an ablate and pace

indication.

•

The cumulative enrollment duration was 416.7 months

with a mean duration of 9.7 months for Group 1, 522.4

months with a mean duration of 10.4 months for

Group 2, and 261.1 months with a mean duration of

10.4 months for Group 3. 73 (61.9%) of the study

patients had enrollment durations greater than 6 months.

•

There were 158 adverse events (115 observations in

68 patients and 43 complications in 34 patients). There

were no unanticipated adverse device effects reported.

The overall protocol violation non-compliance rate is

0.4% in Group 1, 0.5% in Group 2, and 0.4% in Group 3.

The overall follow-up compliance rate is 99.8% in all

groups.

•

There were 3 patient deaths reported, two in Group 2

and one in Group 3. The clinical investigators and

clinical events committee determined that none of these

deaths were related to the study devices.

Both the CRT pacing and the RV pacing only groups

showed improvements in the primary composite

endpoint of quality of life and six-minute walk distance

between the baseline evaluation and the six-month

follow-up. In addition, there was a trend towards

improvement between the combined CRT pacing groups

compared to the RV pacing only group at six months.

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Stratos LV/LV-T Technical Manual 29

Primary Endpoint—Complication-free Rate (Safety)

The safety of the Stratos LV was evaluated based on

complications (adverse events that require additional invasive

intervention to resolve) related to the implanted CRT system

which includes the Stratos LV, the right ventricular, the left

ventricular lead, lead ventricular lead adapters (if used) and the

implant procedure. The target complication-free rate at six

months is 85%.

13 complications in these categories were seen in 11 patients

with cumulative enrollment duration of 783.5 months

(64.4 patient-years). 14.7% of the patients had a reported

complication in these categories. The rate of complications per

patient-year is 0.20. Details of the Stratos LV complications in

the AVAIL CLS/CRT study are listed in Table 4.

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30 Stratos LV/LV-T Technical Manual

Table 4: AVAIL CLS/CRT Complication-Free Rate at

6 months – Stratos LV

Number

Patients

Complications

per patient-

year

% of

Number of

Category

Patients Complications

Device-Related

Pocket

Infection/Pain

1.3%

0.03

Total

1.3%

0.03

LV Lead Related

High Threshold

No Capture

Diaphragmatic

Stimulation

1.3%

0.02

1.3%

2.7%

Dislodgement

0.03

Total

5.3%

0.06

RV Lead Related

High Threshold

/ No Capture

Total

5.3%

0.06

5.3%

0.06

Procedure

1.3%

Pneumothorax

User error

Hematoma

Total

0.02

0.05

1.3%

4.0%

Total Lead

and

Procedure

14.7%

0.20

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Stratos LV/LV-T Technical Manual 31

Table 4: AVAIL CLS/CRT Complication-Free Rate at

6 months – Stratos LV

Number

Patients

Complications

per patient-

year

% of

Number of

Category

Patients Complications

Other Medical

Worsening

CHF

Repeat

2.7%

4.0%

0.03

0.05

Ablation

Non-CHF

cardiac

4.0%

0.05

symptoms

Other Medical

4.0%

0.05

Total

13.3%

0.17

Total—All

Patients and

Category

Device-Related

2.7%

Pocket

Infection or

Pain

0.05

2.7%

Total

LV Lead-Related

High

Threshold /

No Capture

Diaphragmatic

Stimulation

1.3%

0.02

1.3%

Dislodgement

2.7%

0.03

5.3%

0.06

Total

RV Lead Related

High

Threshold /

No Capture

5.3%

0.06

5.3%

0.06

Total

Procedure

1.3%

4.0%

Pneumothorax

User error

Hematoma

Total

0.02

0.05

Total Lead

and

Procedure

14.7%

0.22

Other Medical

Worsening

CHF

Non-CHF

cardiac

2.7%

0.03

0.08

6.7%

symptoms

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34 Stratos LV/LV-T Technical Manual

Table 5: Summary of Complications – Stratos LV

Number

Patients

Complications

per patient-

year

% of

Patients

Number of

Complications

Category

Repeated

ablation

4.0%

0.05

Lead addition

Other medical

Total

1.3%

4.0%

16.0%

0.02

0.05

0.22

Total—All

Patients and

Category

Patients Complications

LV Lead-Related

High Threshold

/ No Capture

1.3%

0.02

Diaphragmatic

Stimulation

17.3%

0.20

18.7%

0.22

Total

Device Related

Pocket Infection

or pain

6.7%

0.08

6.7%

Procedure

1.3%

0.08

Total

Pneumothorax

Atrial edema

User error

Total

0.02

0.05

4.0%

Total Lead,

Device and

Procedure

25.3%

0.34

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Stratos LV/LV-T Technical Manual 35

Table 6: Summary of Observations – Stratos LV

Number

Patients

Observations

per patient-

year

% of

Number of

Category

Patients Complications

Other Medical

4.0%

Dizziness

Other Medical

Worsening CHF

0.05

0.53

0.12

32.0%

10.7%

Ventricular

arrhythmias

2.7%

0.03

Shortness of

Breath

Stroke / TIA

6.7%

1.3%

0.08

0.02

Non-CHF

cardiac

symptoms

Total

Total—All

1.3%

46.7%

60.0%

0.02

0.84

1.18

Patients and

Category

Mean ± SE

2-sided)

Mean ± SE

Distance Walked

at Baseline

262.8 ± 13.7

312.8 ± 14.6

50.0 ± 12.2

39.0% ± 13.1%

58.5 ± 2.9

288.5 ± 22.4 0.369^*

345.8 ± 30.0 0.303^*

Distance Walked

at Six-Months

∆ Distance

Walked (meters)

57.2 ± 26.7

0.790^*

0.610^*

0.137^*

0.731^*

0.367^*

0.537^*

∆ Distance

Walked (%)

25.7% ±

15.0%

QOL Score at

Baseline

49.3 ± 5.5

27.7 ± 6.5

21.6 ± 7.7

QOL Score at

Six-Months

30.1 ± 3.2

∆ in QOL Score

28.4 ± 3.4

∆ in QOL Score

40.4% ±

11.1%

47.4% ± 5.1%

(%)

33.0% ±

12.3%

Composite Rate

43.2% ± 7.7%

0.525^*

p value is provided for informational purposes to show trends only; clinical

significance is not indicated by p values for analyses that were not prespecified.

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38 Stratos LV/LV-T Technical Manual

Primary Effectiveness Endpoint Analysis and Conclusions

The primary effectiveness endpoint evaluated CRT effectiveness

(Groups 1 and 2) compared to RV only effectiveness (Group 3),

as measured by the composite rate of the six minute walk test

and QOL improvement from Baseline to the Six-Month follow-up

(Table 8). For this analysis, both six minute walk test and QOL

were equally weighted at 50%. Due to the small number of

patients with data available for the analysis of the primary

endpoint, the results lack power to demonstrate that biventricular

pacing with either the Protos DR/CLS or Stratos LV device is

statistically different from RV only pacing with the Stratos LV

device in patients undergoing an “ablate and pace” procedure.

Multi-site Poolability and Gender Analysis

The AVAIL CLS/CRT clinical report included data from multiple

centers with centralized coordination, data processing, and

reporting at BIOTRONIK. All of the clinical centers followed the

requirements of an identical clinical protocol, and all of the

clinical centers used the same methods to collect and report the

clinical data, including New York Heart Association evaluation,

six-minute walk test, Minnesota Living with Heart Failure

questionnaire, and echocardiographic measurements. In order

to justify pooling of the data from multiple centers, several

analyses were completed. All of the centers were divided into

two groups (Small and Large sites) based on implant volume.

Comparisons were then made between the patient populations

based on the results of the safety and effectiveness endpoints.

Additionally, analyses were performed on the data collected in

the AVAIL clinical investigation in order to compare results

between males and females.

The first type of analysis

compared enrollment by patient gender in each of the study

groups. The second type of analysis compared effectiveness

and safety outcomes in each gender.

The results of these analyses demonstrated poolability of the

data between sites. There were no significant differences in the

primary safety or effectiveness endpoints between high and low

volume implant centers.

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Stratos LV/LV-T Technical Manual 39

The gender distribution in this clinical investigation was

consistent within the study groups and included a representative

proportion of enrolled female participants (57.2% versus 42.7%

male). There were no significant differences in the primary

safety or effectiveness endpoints between the male and female

population.

1.7.2 Stratos LV Clinical Study – OVID study

The OVID clinical study collected significant safety data

supporting the Stratos LV/LV-T CRT-P system.

Study Design

BIOTRONIK conducted the Corox Over-the-Wire Lead

Evaluation (OVID) prospective registry outside the United States

(OUS) of the Corox OTW Steroid LV lead in a multi-center trial

with legally marketed CRT-D and CRT-P pulse generators that

provide biventricular pacing therapy. Data from this registry is

presented in the following sections to support the safety of the

Stratos LV CRT-P.

The multi-center investigation was designed to validate the

safety of the Corox OTW Steroid LV lead through a comparison

of successfully implanted LV leads against a pre-defined

success rate threshold, when no anatomical restrictions prevent

access to the coronary sinus. The evaluation of safety is based

on the analysis of the incidence of adverse events, defined as

any complications or observations judged by the investigator to

be in probable relationship with Corox OTW Steroid LV lead

system.

Additionally, the effectiveness of the leads was

evaluated using lead parameter data, including sensing

amplitudes, pacing thresholds, and impedance values.

In the OVID study, enrolled patients could be implanted with any

legally marketed CRT-P or CRT-D device. There were 121

patients enrolled in the OVID clinical study, and 89 patients were

implanted with a Stratos LV device.

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40 Stratos LV/LV-T Technical Manual

Clinical Inclusion Criteria

To support the objectives of this investigation, patients were

required to meet the following inclusion criteria prior to

enrollment:

•

Meet the indications for bi-ventricular pacing

Age ≥ 18 years

Receiving optimal drug therapy for Congestive Heart

Failure treatment

•

Give informed consent

Clinical Exclusion Criteria

To support the objectives of this investigation, the exclusion

criteria at the time of patient enrollment included the following

requirements:

•

Myocardial infarction or unstable angina pectoris

Acute myocarditis

Life expectancy ≤ 6 months

Planned cardiac surgical procedures or interventional

measures within the next 6 months

•

Pregnancy

Follow-Up Schedule

All patients were implanted with the Corox OTW/Steroid LV lead

system and a CRT-P or CRT-D pulse generator capable of

providing bi-ventricular pacing for the treatment of CHF. The

specific study procedures were performed at:

•

Pre-operative Visit

Implantation

Pre-discharge follow-up

One-month follow-up

Three-month follow-up

Six-month follow-up

Twelve-month follow-up

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Stratos LV/LV-T Technical Manual 41

Clinical Endpoints

The safety of the Stratos LV was evaluated based on

complications (adverse events that require additional invasive

intervention to resolve) related to the implanted CRT system

which includes the Stratos LV device, the atrial lead, the right

ventricular lead the left ventricular lead and the implant

procedure. The target complication-free rate at six months was

85%.

Accountability of PMA Cohorts

During the OVID study, 84 patients were implanted with the

Stratos LV CRT-P and Corox OTW/Steroid LV lead system.

Additionally, 5 other patients were implanted with a Stratos LV

CRT-P device following an unsuccessful Corox OTW/Steroid LV

lead implant attempt. Of these 5 patients, three were not

implanted with any LV pacing lead, one was implanted with a

non-study LV pacing lead and one was implanted with a

BIOTRONIK Elox P 60 BP placed in the RV outflow tract for

bi-focal ventricular pacing. These 5 patients were excluded from

the OVID study at 1 month post-implant, because the primary

endpoint of the OVID study was the evaluation of the safety and

effectiveness of the Corox OTW/Steroid lead.

Demographics and Baseline Parameters

Table 9 provides a summary of the patient demographics and

medical history for the 89 enrolled patients implanted with a

Stratos LV. The typical patient implanted with a Stratos LV

CRT-P was a 68 year old male with NYHA Class III heart failure,

Left Bundle Branch Block (LBBB), a mean QRS duration of

160 ms, and non-ischemic cardiomyopathy.

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42 Stratos LV/LV-T Technical Manual

Table 9: Patient Demographics

Characteristic

Age at Implant (Years)

Results

n=88

Mean ± SD

Range

Gender

68 ± 10

34 to 84

n=89

Male

Female

66 (74%)

23 (26%)

n=70

160 ± 23

110 to 210

n=87

QRS-width (ms)

Mean ± SD

Range

Etiology of Heart Failure

Ischemic

32 (37%)

55 (63%)

Non-Ischemic

New York Heart Association (NYHA)

Classification

n=87

Class III

Class IV

Atrial Tachyarrhythmias

None

Atrial flutter

73 (84%)

14 (16%)

N=87

48 (55%)

5 (5.7%)

19 (22%)

Paroxysmal atrial fibrillation

(11.5%)

Persistent atrial fibrillation

Other

5 (5.7%)

N=87

Ventricular Tachyarrhythmias

None

Ventricular fibrillation

Sustained or non-sustained VT

Other VT

80 (92%)

5 (5.7%)¹⁾

2 (2.3%)²⁾

Existing/chronic leads prior to Corox

OTW/Steroid

n=88

None

73 (83%)

15 (17%)

Yes, due to previous pacemaker therapy

¹⁾non-sustained VT (n=4); no further information available (n=1); ²⁾VES (n=2)

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Stratos LV/LV-T Technical Manual 43

Safety and Effectiveness Results

•

The cumulative implant duration was 760 months with a

mean duration of 9.2 months. Sixty-five (77%) of the

patients had implant durations greater than 6 months.

•

The implant success rate for the Stratos LV CRT-P was

100% (89 out of 89). The implant success of the

Stratos LV

CRT-P

combination

with

the

Corox OTW/Steroid LV lead was 94.4% (84 out of 89).

•

The mean LV pacing threshold at implant was 0.9 and at

6-months was 0.9 volts.

•

The mean R-wave at implant was 15.7 mV.

The mean LV lead impedance at implant was 729 ohms

and at 6-months was 603 ohms.

•

There were 29 adverse events (18 observations in

17 patients and 11 complications in 10 patients). There

were no unanticipated adverse device effects reported.

There were 10 patient deaths reported in the OVID

study. The clinical investigators have determined that

no deaths were related to the Stratos LV CRT-P system.

The overall follow-up compliance rate for the OVID study

is 93%.

Primary Endpoint—Complication-free Rate (Safety)

The safety of the Stratos LV was evaluated based on

complications (adverse events that require additional invasive

intervention to resolve) related to the implanted CRT system

which includes the Stratos LV device, the atrial lead, the right

ventricular lead, the left ventricular lead and the implant

procedure. The target complication-free rate at six months was

85%.

Ten (10) complications in these categories were seen in

10 patients with cumulative implant duration of 760 months

(63.3 patient-years). 11.2% of the patients had a reported

complication in these categories. The rate of complications per

patient-year was 0.16. Details of the Stratos LV complications in

the OVID study are listed in Table 10.

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44 Stratos LV/LV-T Technical Manual

The freedom from Stratos LV system-related and procedure-

related complications was 88.76% with a one sided lower 95%

confidence bound of 81.69%. Therefore, the null hypothesis was

rejected, and it was concluded that the complication-free rate at

6 months is equivalent to 85% within 10% (p = 0.0014).

Observed Adverse Events

Adverse events are classified as either observations or

complications. Observations are defined as clinical events that

do not require additional invasive intervention to resolve.

Complications are defined as clinical events that require

additional invasive intervention to resolve.

Of the 29 adverse events reported, there were 18 observations

and 11 complications in a total of 89 patients. Table 10 and

Table 11 provide a summary by category of each type of

adverse event (complications and observations).

Table 10: Summary of Complications at 6 months

Number

Complications

per patient-

year

% of

Number of

Category

Patients Complications

Patients

Corox OTW/Steroid Lead-Related

Loss of

capture

2.2%

0.03

Phrenic nerve

stimulation

1.1%

0.02

3.3%

0.05

Total

Atrial Lead Related

Loss of

capture

1.1%

0.02

1.1%

0.02

Total

RV Lead Related

Loss of

capture

3.3%

0.05

Elevated

Pacing

2.2%

0.03

thresholds

5.6%

0.08

Total

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Stratos LV/LV-T Technical Manual 45

Table 10: Summary of Complications at 6 months

Number

Complications

per patient-

year

% of

Number of

Category

Patients Complications

Patients

Device Related

Pocket

infection

Total

Total System

1.1%

0.02

0.16

11.2%

Other Medical

1.1%

Arrhythmias

Total

0.02

Overall

Complication

Totals

11.2%

0.17

Number of Patients = 89; Number of Patient-Years = 63.3

Table 11: Summary of Observations at 6 months

Observations

per patient-

year

Number of

Patients Patients Observations

% of

Number of

Category

Corox OTW/Steroid Lead-Related

Implant failure

Phrenic nerve

stimulation

5.6%

4.5%

0.08

0.06

0.14

10.1%

Total

Atrial Lead Related

Loss of

capture

1.1%

0.02

1.1%

0.02

Total

RV Lead Related

Elevated

Pacing

2.2%

0.03

thresholds

2.2%

0.03

Total

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46 Stratos LV/LV-T Technical Manual

Table 11: Summary of Observations at 6 months

Observations

per patient-

year

Number of

Patients Patients Observations

% of

Number of

Category

Device Related

Pocket

infection/

Pericardial

Effusion

1.1%

0.02

1.1%

0.02

0.21

Total

Total System

13.5%

Medical

Arrhythmias

Shortness of

breath,

palpitations

Total

2.2%

0.03

0.02

0.05

1.1%

3.3%

Miscellaneous

Malfunction of

hemostatic

valve

1.1%

0.02

Improper

Lead

preparation

Total

Overall

1.1%

2.2%

0.02

0.04

0.28

19.1%

Observation

Totals

Number of Patients = 89; Number of Patient-Years = 63.3

There were a total of 10 patient deaths reported in the OVID

study for patients with the Stratos LV device. The clinical

investigators determined that no deaths were related to the

Stratos LV device system.

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Stratos LV/LV-T Technical Manual 47

1.7.3 AVAIL and OVID Combined Primary

Endpoint-Complication-free Rate (Safety)

The results from for the AVAIL CLS/CRT and OVID studies were

pooled to evaluate the safety of the Stratos LV device. The

safety of the Stratos LV was evaluated based on complications

(adverse events that require additional invasive intervention to

resolve) related to the implanted CRT system which includes the

Stratos LV, the atrial lead, the right ventricular lead, the left

ventricular lead and the implant procedure.

complication-free rate at six months was 85%.

The target

Twenty-three (23) complications in these categories were seen

in 21 patients with cumulative implant duration of 127.7 years.

12.8% of the patients had a reported complication in these

categories. The rate of complications per patient-year was 0.18.

Details of the Stratos LV complications in the AVAIL CLS/CRT

and OVID studies are listed in Table 12.

Table 12: OVID and AVAIL Complication-Free

Rate - Stratos LV

Number

Patients

Complications

per patient-

year

% of

Number of

Category

Patients Complications

LV Lead-Related

High

Threshold / No

Capture

Diaphragmatic

Stimulation

1.8%

0.02

1.2%

Dislodgement

0.01

Total

4.3%

0.06

RV Lead Related

High

Threshold / No

Capture

Total

5.5%

0.07

5.5%

0.07

Atrial Lead Related

No Capture

0.6%

0.01

Total

0.6%

0.01

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48 Stratos LV/LV-T Technical Manual

Table 12: OVID and AVAIL Complication-Free

Rate - Stratos LV

Number

Patients

Complications

per patient-

year

% of

Number of

Category

Patients Complications

Device Related

Pocket

Infection

Total

1.2%

0.02

1.2%

0.02

Procedure

0.6%

1.8%

Pneumothorax

User error

Hematoma

Total

0.01

0.02

Total Lead,

Device and

Procedure

12.8%

0.18

Other Medical

Arrhythmias

Repeated

ablation

0.6%

0.01

0.02

1.8%

Worsening

CHF

Other Medical

Non-CHF

cardiac

1.2%

1.8%

0.02

1.8%

6.7%

0.02

0.09

0.27

symptoms

Total

Total—All

Patients and

Categtories

17.7%

Number of Patients = 164 Number of Patient-Years = 127.7

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Stratos LV/LV-T Technical Manual 49

The freedom from Stratos LV system-related and procedure-

related complications was 87.2% with a one sided lower 95%

confidence bound of 82.09%. Therefore, the null hypothesis was

rejected, and it was concluded that the complication-free rate at

6 months is equivalent to 85% within 10% and the primary safety

endpoint was met (p = 0.0002)^*.

1.7.4 Tupos LV/ATx Clinical IDE Study -

OPTION CRT/ATx

The CRT functionality of the Stratos CRT-P devices is based on

the FDA approved Tupos LV/ATx. Therefore, the data from the

OPTION CRT/ATx study supports the effectiveness of CRT.

The OPTION CRT/ATx study was conducted on the Tupos

LV/ATx, a device that delivers CRT but, in addition, also offers

defibrillation therapy (CRT-D).

Study Design

The purpose of the prospective, randomized, multi-center

OPTION CRT/ATx study was to demonstrate the safety and

effectiveness of the investigational Tupos LV/ATx Cardiac

Resynchronization Therapy Defibrillator (CRT-D) in patients with

congestive heart failure (CHF) and atrial tachyarrhythmias.

Patients in the study group were implanted with a BIOTRONIK

Tupos LV/ATx. Patients in the control group were implanted with

any legally marketed CRT-D. Patients in both the study and

control groups were implanted with a legally marketed left

ventricular lead.

p value is provided for informational purposes to show trends only; clinical

significance is not indicated by p values for analyses that were not prespecified.

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50 Stratos LV/LV-T Technical Manual

Primarily, the study evaluates and compares the functional

benefits of CRT between the two randomized groups using a

composite endpoint consisting of a six-minute walk test (meters

walked) and quality of life measurement (assessed using the

Minnesota Living with Heart Failure Questionnaire). Relevant

measurements were completed twice for each patient: once at

the Baseline evaluation (two-week post implant follow-up) and

again at a six-month follow-up evaluation. The data collected

during this clinical study was used to demonstrate equivalent

treatment of CHF in both the study and control groups. This

study also evaluated other outcomes including: the percentage

of time CRT is delivered, and other measures of CHF status,

including NYHA classification, peak oxygen consumption during

metabolic exercise testing, and the rate of hospitalization for

CHF.

Clinical Inclusion Criteria

To support the objectives of this investigation, patients were

required to meet the following inclusion criteria prior to

enrollment:

•

Stable, symptomatic CHF status

NYHA Class III or IV congestive heart failure

Left ventricular ejection fraction ≤ 35% (measured within

six-months prior to enrollment)

•

Intraventricular conduction delay (QRS duration greater

than or equal to 130 ms)

For patients with an existing ICD, optimal and stable

CHF drug regimen including ACE-inhibitors and beta-

blockers unless contraindicated (stable is defined as

changes in dosages less than 50% during the last

30 days)

•

Indicated for ICD therapy

History or significant risk of atrial tachyarrhythmias

Willing to receive possibly uncomfortable atrial shock

therapy for the treatment of atrial tachyarrhythmias

•

Able to understand the nature of the study and give

informed consent

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Stratos LV/LV-T Technical Manual 51

•

Ability to tolerate the surgical procedure required for

implantation

Ability to complete all required testing including the six-

minute walk test and cardiopulmonary exercise testing

Available for follow-up visits on a regular basis at the

investigational site

Age greater than or equal to 18 years

Clinical Exclusion Criteria

To support the objectives of this investigation, the exclusion

criteria at the time of patient enrollment included the following:

•

Previously implanted CRT device

ACC/AHA/NASPE indication for bradycardia pacing

(sinus node dysfunction)

•

Six-minute walk test distance greater than 450 meters

Chronic

atrial

tachyarrhythmias

refractory

cardioversion shock therapy

•

Receiving intermittent, unstable intravenous inotropic

drug therapy (patients on stable doses of positive

inotropic outpatient therapy for at least one-month are

permitted)

•

Enrolled in another cardiovascular or pharmacological

clinical investigation

•

Expected to receive a heart transplant within 6 months

Life expectancy less than 6 months

Presence of another life-threatening, underlying illness

separate from their cardiac disorder

•

Acute myocardial infarction, unstable angina or cardiac

revascularization within the last 30 days prior to

enrollment

Conditions that prohibit placement of any of the lead

systems

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52 Stratos LV/LV-T Technical Manual

Follow-Up Schedule

After successful enrollment, all patients were randomly assigned

to either the study group or the control group. The specific

procedures of this study were:

•

Pre-enrollment screening

Randomization

System implantation

Pre-discharge follow-up

Baseline evaluation / CRT activation

One-Month follow-up

Three-Month follow-up

Six-Month follow-up

Subsequent routine follow-ups (every three months)

Clinical Endpoints

Primary Endpoint 1: Six Minute Walk Test & QOL (Effectiveness)

The purpose of Primary Endpoint 1 is to evaluate the

effectiveness of the Tupos LV/ATx system in providing CRT as

measured by the average composite rate of improvement in six

minute walk test and QOL.

Secondary Endpoint Results

1. The purpose of this secondary endpoint is to evaluate

improvement in functional capacity as measured by the six

minute walk test. The six minute walk test is a well-accepted

measure of functional capacity and exercise tolerance. Also,

this test more closely mimics the patient’s day-to-day

activities than maximal exercise testing.

2. The purpose of this secondary endpoint is to evaluate the

improvement in the patient’s NYHA classification.

Accountability of PMA Cohorts

After randomization and enrollment, 7 patients (4 in the study

group and 3 in the control group) did not receive an implant. The

reasons for patients not receiving an implant are outlined in

Figure 2.

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Stratos LV/LV-T Technical Manual 53

Enrolled and Randomized

Patients

Study

Control

133

No implant Attempted

Withdrawal of Consent

Study

Control

Not Meeting Inclusion Criteria

Study

Control

Implant Attempted

Study

Control

130

Unsuccessful implant

Withdrawal of IC before 2nd Attempt

Study

Control

Expired before Second Attempt

Study

Control

Successful implant

Study

Control

129

6-Month Follow-up Data

Patient Death before 6-Month

Study

Control

Withdrawal before 6-Month

Study

Control

Not Reached 6-Month FU

or Data Pending

Patients completed 6-Month

Follow-up

Study

Control

Study

Control

100

Figure 2: Patient Accountability

Demographics and Baseline Parameters

Table 13 provides summary of the pre-enrollment

demographics of enrolled patients.

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54 Stratos LV/LV-T Technical Manual

Table 13: Patient Demographics at Pre-Enrollment

Study

N=133

Control

N=67

P-

value

Characteristic

Age at Enrollment (Years)

Mean ± SE

Range

0.781*

69.5 ± 0.9

43 to 88

69.1 ± 1.2

38 to 84

Gender

Male

Female

93 (69.9%) 51 (76.1%) 0.407**

40 (30.1%) 16 (23.9%)

Underlying Heart Disease

Ischemic Cardiomyopathy

Nonischemic Cardiomyopathy

100 (75.2%) 54 (80.6%) 0.294***

34 (25.6%) 15 (22.4%)

Type of Bundle Branch Block

Left Bundle Branch Block

Right Bundle Branch Block

Other

91 (68.4%) 49 (73.1%)

0.877***

26 (19.5%) 10 (14.9%)

19 (14.3%) 11 (16.4%)

New York Heart Association

Class

Class III

Class IV

0.800**

121 (91.0%) 60 (89.6%)

12 (9.0%)

7 (10.4%)

Intrinsic QRS Duration (ms)

Mean ± SE

0.073*

0.255*

161.9 ± 2.0 156.1 ± 2.3

130 to 252

130 to 200

Range

Left Ventricular Ejection

Fraction (%)

Mean ± SE

22.1 ± 0.6

23.3 ± 0.8

10 to 35

5 to 35

Range

Six Minute Walk Distance

(meters)

0.775*

250.5 ±

11.9

27 to 447

Mean ± SE

Range

254.8 ± 8.9

20 to 451

Quality of Life Questionnaire

Score

Mean ± SE

Range

0.638*

54.3 ± 2.1

0 to 105

52.5 ± 3.1

0 to 102

*Student's t-test (2-sided) for means, **Fisher's Exact Test (2-sided) for 2

possible answers, ***Chi-Square test (2-sided) for more than 2 possible answers

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Stratos LV/LV-T Technical Manual 55

Table 14 provides a summary of cardiac medications patients

were taking at the time of enrollment. Some categories may be

more than 100% as several categories allow more than one

response.

Table 14: Cardiac Medications at Pre-Enrollment

Drug

Category

Study

(N=133)

Control

(N=67)

P-

value

Specific CHF Medications

ACE inhibitors

Angiotensin receptor blockers

Beta blockers

Cardiac glycosides (Digoxin)

Diuretic

89 (66.9%) 45 (67.2%) 1.000**

21 (15.8%) 16 (23.9%) 0.180**

111 (83.5%) 55 (82.1%) 0.843**

60 (45.1%) 35 (52.2%) 0.370**

114 (85.7%) 57 (85.1%) 1.000**

Inotropes

1 (0.8%)

34 (25.6%)

36 (27.1%)

3 (4.5%) 0.110**

19 (28.4%)

0.735**

14 (20.9%)

0.390**

Anti-arrhythmics

Nitrates

*Student's t-test (2-sided) for means, **Fisher's Exact Test (2-sided) for 2

possible answers, ***Chi-Square test (2-sided) for more than 2 possible answers

Safety and Effectiveness Results

A total of 200 patients were enrolled in the OPTION CRT/ATx

clinical study at 25 sites:

There were 133 study patients and 67 active control patients in

this prospective, multi-center, randomized clinical study. For the

study group, there were 129 successful implants (91.4%) of the

Tupos LV/ATx CRT-D system. For the active control group,

there were 64 successful implants (92.2%) of the legally

marketed CRT-D systems.

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56 Stratos LV/LV-T Technical Manual

•

There were 192 endocardial and 19 epicardial leads

implanted in 193 patients. Investigators were allowed to

choose among any legally marketed LV lead according

to their familiarity with the lead and patient anatomy. The

Tupos LV/ATx CRT-D was implanted with 7 endocardial

and

epicardial lead models from

different

manufacturers. There were no adverse events reported

attributable to lead-generator incompatibility.

•

The cumulative implant duration is 1240.4 months with a

mean duration of 9.6 months for the study group. The

cumulative implant duration is 596.5 months with a

mean duration of 9.3 months for the control group.

The overall protocol compliance rate is 79.2% in the

study group and 85.9% in the control group. The overall

follow-up compliance rate is 99.4% in the study group

and 98.3% in the control group.

There have been 10 patient deaths reported in the study

group and 4 patient deaths reported in the control group.

The clinical investigators have determined that no

deaths were related to the study device.

Primary Endpoint 1: Six Minute Walk Test

(Effectiveness)

QOL

The purpose of Primary Endpoint 1 is to evaluate the

effectiveness of the Tupos LV/ATx system in providing CRT as

measured by the average composite rate of improvement in six

minute walk test and QOL.

Table 15 presents the average composite rate of improvement in

six minute walk test distance and QOL score, the average 6-

minute walk test distance and the average QOL score at

Baseline and at the Six-Month follow-up, as well as the average

difference in 6-minute walk test distance and QOL score

between Baseline and the Six-Month follow-up for the Study and

Control Groups for those patients with six minute walk test data

and complete QOL data at both Baseline and the Six-Month

follow-up.

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Stratos LV/LV-T Technical Manual 57

Table 15: Composite of Six Minute Walk Test and QOL

(Effectiveness)

Study Group

(N = 74)

Mean ± SE

Control Group

(N = 38)

Mean ± SE

P-value^*

Category

Distance

Walked at

Baseline

Distance

Walked at

Six-Months

310.51 ± 10.89

340.77 ± 12.32

288.76 ± 15.37

301.84 ± 17.02

0.249

0.067

∆ Distance

Walked

30.26 ± 10.40

17.27% ± 5.59%

13.08 ± 13.05

8.71% ± 5.26%

0.322

0.326

QOL Score at

Baseline

44.39 ± 2.78

28.68 ± 2.66

45.53 ± 4.13

33.95 ± 4.35

0.817

0.279

QOL Score at

Six-Months

11.58 ± 3.45

-13.42% ±

34.54%

∆ in QOL

Score†

15.72± 2.83

19.08% ± 12.21%

0.376

0.281

Composite

Rate^‡

18.18% ± 7.07% -2.36% ± 17.73% 0.030

The calculated p-values are associated with a Student's t-test (2-sided) of the

equality of means in the two groups, except for the p-value of the composite rate,

which is associated with a test of equivalence (non-inferiority).

†

∆ in QOL Score is calculated as the average of the individual differences

between Baseline and Six-Months for each patient. Negative values for mean ∆

QOL in percent are possible when positive mean values for absolute changes in

QOL are recorded. In some cases, small, negative changes in absolute QOL

scores resulted in relatively large percentage changes.

‡

The Composite Rate (=(∆ Distance Walked (%) + ∆ QOL Score (%)) / 2) is

calculated for each patient and then averaged to obtain the Composite Rates.

For all calculations, a positive number represents improvement from Baseline to

Six-Months.

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58 Stratos LV/LV-T Technical Manual

Primary Effectiveness Endpoint Analysis and Conclusions

A composite rate of six minute walk test and QOL improvement

from Baseline to the Six-Month follow-up is evaluated as a

measure of CRT effectiveness. For this analysis both six minute

walk test and QOL are equally weighted at 50%.

The mean difference in the composite rate between study and

control group was 20.53% with an associated one-sided, 95%

confidence bound of (-6.10%). The p-value for non-inferiority

within 10% is 0.030. The analysis of the composite rate in six

minute walk test distance and QOL score demonstrates that the

study group is non-inferior to the control group and that the

primary effectiveness endpoint was met (p=0.030).

Secondary Endpoint Results

1. The purpose of this secondary endpoint is to evaluate

improvement in functional capacity as measured by the six

minute walk test. The six minute walk test is a well-accepted

measure of functional capacity and exercise tolerance. Also,

this test more closely mimics the patient’s day-to-day

activities than maximal exercise testing.

Table 16 summarizes the six minute walk test distance at

Baseline and the Six-Month follow-up for patients in the

study group and the control group.

Table 16: Six Minute Walk Distance

Distance

Study

Control

(meters)

Baseline

127

Mean ± SE

Range

Median

Six-Month

283.14 ± 9.27

23 to 511

302.00

269.43 ± 13.77

29 to 507

244.00

Mean ± SE

Range

Median

* Student's t-test, 2-sided

329.73 ± 10.82

78 to 596

335.00

310.70 ± 15.49

91 to 489

313.00

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Stratos LV/LV-T Technical Manual 59

There are no clinically relevant differences in the six minute walk

test results between the study and the control group.

2. The purpose of this secondary endpoint is to evaluate the

improvement in the patient’s NYHA classification. Table 17

summarizes the average improvement in NYHA from

Baseline to Six-Months for 140 patients that were able to

complete both NYHA classification evaluations.

Table 17: Improvement in NYHA Classification at

Six-Months from Baseline

Study

(N=97)

Control

(N=43)

Change in

% of

Total

Patients

NYHA class

Number of % of Total Number of

Patients

10.3%

48.5%

Patients

Improved 2

classes

Improved 1

class

4.7%

46.5%

Total

improved

No change

Worsened 1

class

58.8%

40.2%

1.0%

51.2%

46.5%

2.3%

The study and the control group have similar NYHA classes and

similar rates of improvement in NYHA class from Baseline to the

Six-Month follow-up.

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60 Stratos LV/LV-T Technical Manual

Multi-site Poolability and Gender Analysis

The OPTION CRT/ATx clinical report includes data from multiple

centers with centralized coordination, data processing, and

reporting at BIOTRONIK. All of the clinical centers followed the

requirements of an identical clinical protocol, and all of the

clinical centers used the same methods to collect and report the

clinical data. In order to justify pooling of the data from multiple

centers, several analyses were completed. All of the centers

were divided into two groups based on implant volume.

Comparisons were then made between the patient populations

based on the results of each of the endpoints. Additionally,

analyses were performed on the data collected in the

OPTION CRT/ATx clinical investigation in order to compare

results between males and females. The first type of analysis

compared enrollment by patient gender in each of the study and

control groups. The second type of analysis compared

effectiveness outcomes in each gender.

The results of these analyses demonstrate poolability of the data

between sites. There were no significant differences in the

second primary endpoint or any of the secondary endpoints

between high and low volume implant centers.

The gender distribution in this clinical investigation is consistent

within the study groups and includes a representative proportion

of enrolled female participants (28.0% versus 72.0% male).

There were no significant differences in any of the primary or

secondary endpoints between the male and female population.

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Stratos LV/LV-T Technical Manual 61

1.7.5 Conclusions Drawn from Studies

The clinical study results support the safety and effectiveness of

the Stratos LV CRT-P device.

•

The OPTION CRT/ATx clinical study completed and

reviewed under P050023 provided reasonable

assurance that bi-ventricular pacing is effective in NYHA

class III/IV heart failure patients with a prolonged QRS

and a left ventricular ejection fraction <35%. The

addition of ICD back-up therapy does not affect the

biventricular pacing performance of the device.

•

The AVAIL CLS/CRT and Corox (OVID) clinical studies

demonstrated the safety of the Stratos LV CRT-P in

NYHA class III/IV heart failure patients with a prolonged

QRS and

left ventricular ejection fraction

<35%.(OVID).

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62 Stratos LV/LV-T Technical Manual

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Stratos LV/LV-T Technical Manual 63

2. Programmable Parameters

For a complete list of programmable parameters and the

available settings for the Stratos CRT-Ps, see Section 11.

2.1

Pacing Modes

For a complete list of pacing modes available in each

Stratos CRT-P configuration, see Section 11.1.

2.1.1 Rate-adaptive Modes

The rate-adaptive modes are designated with an “R” in the fourth

position of the NBG pacemaker code on the programmer screen.

The rate-adaptive modes function identically to the

corresponding non-rate-adaptive modes, except that the basic

rate increases when physical activity is detected by the motion

sensor.

In demand modes (i.e., DDDR, DDIR, DVIR, VDDR, VVIR,

AAIR), it is possible that the atrial and/or ventricular refractory

period can comprise a major portion of the basic interval at high

sensor-modulated rates.

This may limit the detection of

spontaneous events or even exclude their recognition altogether.

WARNING

Rate Adaptive Pacing – Use rate-adaptive pacing with care

in patients unable to tolerate increased pacing rates.

2.1.2 DDD

The timing of the Stratos CRT-Ps is based on atrial events.

In the case of an atrial sensed or paced event, the AV delay

starts the same time as the basic interval. If a ventricular sensed

event does not occur within the AV delay, ventricular pacing is

initiated at the end of the AV delay. If ventricular sensing occurs

within the AV delay, ventricular pacing is inhibited.

If atrial sensing occurs outside the atrial refractory period, atrial

pacing is inhibited and the basic interval is restarted.

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64 Stratos LV/LV-T Technical Manual

In the case of ventricular sensed events outside of the AV delay

and the VES discrimination interval after

ventricular

extrasystole (VES or PVC), the basic interval starts without

simultaneously starting an AV delay. To protect the atrium from

retrograde conduction, an extended PMT protection window is

started at the same time as the basic interval. If an atrial sensed

event does not occur within the basic interval (but outside the

refractory period), atrial pacing occurs after the basic interval

has elapsed, and the basic interval and AV delay are restarted.

Upon an atrial paced event, the AV safety interval starts with a

long basic interval. If a ventricular sensed event occurs within

the AV delay, ventricular pacing is inhibited.

Table 18 summarizes the intervals initiated by sensing or

pacing. The table distinguishes between two kinds of ventricular

sensed and ventricular paced events: VP at the end of the AV

delay; VP at the end of the safety AV delay, referred to as

ventricular safety pace (V_SP); V_Swithin the AV delay; and V_S

outside of the AV delay, referred to as “ventricular extrasystole”

(VES).

Table 18: Timing Intervals

Timing

Interval

Event

Vp Vsp

Ap As

VS VES

(PMT)

Basic interval

(DDD)^*

Basic interval

(DDI)^†

Atrial refractory

period^‡

Upper basic rate

Ventricular

Refractory

Period

This timing interval is also applicable to the following modes: DDD(R), VDD(R),

AAI(R), DDT, VDT, AAT, DOO(R) and AOO(R)

†

In DDI(R), DVI(R), VVI(R), DVT(R), DDI/T(R) and V00(R) lower rate timing

starts with Vp, and/or Vs, and/or Vs event outside of the AV delay and the VES

discrimination window (VES).

‡

In DDI(R), DDI/T, VDD(R), and VDT, the atrial refractory period will also be

reset upon time-out of the VA-interval whether or not an atrial pulse is emitted.

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Stratos LV/LV-T Technical Manual 65

Table 18: Timing Intervals

Event

Vp Vsp

Timing

Interval

Ap As

VS VES

(PMT)

AV delay

Safety AV delay

Interference

interval (A)

Interference

interval (V)

Blanking time

(A) after Ap

Blanking time

(V) after RVp

Atrial upper rate

(AUR)

Far-field

Protection (A)

PMT Protection

(A)

PMT protection

extension (A)

Trigger Pacing

The triggered pacing modes are identical to the respective

demand modes except that the sensing of an atrial/ventricular

event outside of the refractory period does not result in inhibition

of pacing, but instead a pacing pulse is delivered in the

respective chamber.

The corresponding pacing modes are:

DDD VDD

DDT VDT

DDI

DVI

AAI

VVI

Demand

Pacing

Triggered

pacing

DDI/T DVT

AAT

VVT

However, the following differences exist. There is no AV safety

interval in DDT, DDI/T and DVT pacing modes. The safety

interval is unnecessary as “cross talk” (ventricular sensing of

atrial pulses) can not occur during these modes.

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66 Stratos LV/LV-T Technical Manual

In the DDI/T and DVT pacing modes, the basic interval is not

restarted if ventricular sensing occurs within the AV delay.

CAUTION

Programmed to Triggered Modes – When programmed to

triggered modes, pacing rates up to the programmed upper

limit may occur in the presence of either muscle or external

interference.

Triggered Modes – While the triggered modes (DDT, DVT,

DDTR/A, DDTR/V, DDI/T, VDT, VVT, and AAT) can be

programmed permanently, these modes are intended for use

as temporary programming for diagnostic purposes.

triggered pacing modes, pacing pulses are emitted in

response to sensed signals, and therefore the pacing pulse

can be used as an indicator, or marker of sensed events for

evaluating the sensing function of the pulse generator using

surface ECG.

However, real-time telemetry of marker

channels and/or intracardiac electrogram via the programmer

and programming wand is recommended over the use of a

triggered pacing mode in the clinical setting. A triggered

pacing mode may be preferred in situations where positioning

the programming head over the pulse generator would be

impossible or impractical (i.e., during exercise testing or

extended Holter monitoring).

Another possible application of triggered modes is to ensure

pacing as a short term solution during a period of inhibition of

pacing by extracardiac interference, mechanical noise signals,

or other sensing abnormalities. Because triggered modes

emit pacing pulses in response to sensed events, this may

result in unnecessary pacing during the absolute refractory

period of the myocardium, inappropriate pacing in response to

oversensing of cardiac or extracardiac signals. The risks

associated with triggered pacing include excessive pacing,

arrhythmias due to the R-on-T phenomenon, and early battery

depletion. Therefore, it is important that the triggered modes

are not used for long term therapy, and that the CRT-P is

always returned to a non-triggered permanent program.

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Stratos LV/LV-T Technical Manual 67

2.1.3 DDI

In contrast to DDD mode, the basic interval in the DDI mode is

not restarted by sensed P-waves, but by ventricular sensed or

paced events. The VA delay is started together with the basic

interval. If atrial or ventricular sensing does not occur during the

VA delay, the atrial pacing occurs at the end of the VA delay.

Atrial pacing starts the AV delay. If atrial sensing occurs outside

of the atrial refractory period (ARP), a PMT safety interval or the

FFP (far-field protection) window, atrial pacing is inhibited.

However, the AV delay does not start with a sense event, but at

the end of the VA interval. Therefore, P-waves in the DDI mode

do not trigger ventricular events.

NOTE:

For additional information on far-field protection window, see

Section 2.3 “Timing Functions”.

An atrial sensed event that occurs during the PMT protection

window starts the atrial upper basic rate to avoid pacing during

the vulnerable phase of the atrium. If the interval of the atrial

upper rate is longer than the basic interval, the AV delay is

shortened by that same amount after atrial pacing, but only until

the end of the safety interval.

2.1.4 DVI

The DVI mode is derived from the DDI mode. In contrast to the

latter, atrial sensing does occur. Therefore, atrial pacing is

delivered at the end of the AV delay. Ventricular sensing within

the AV delay inhibits atrial and ventricular pacing. Ventricular

sensing within the AV delay inhibits ventricular pacing.

2.1.5 VDD

The VDD mode corresponds to the DDD mode with the

exception that it does not provide atrial pacing. In the absence

of a sense event, the basic interval starts with either an atrial

sense event, a ventricular extrasystole or after expiration of the

preceding basic interval.

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68 Stratos LV/LV-T Technical Manual

2.1.6 AAI and VVI

The pacing modes AAI and VVI provide atrial and ventricular

demand pacing. The lower rate timer is started by a sense or

pace event. A sense event outside of the refractory period

inhibits pacing and resets the lower rate timer; in the absence of

a sense event, a pulse generator pulse will be emitted at the end

of the lower rate interval.

2.1.7 AAI, VVI

The AAI and VVI single-chamber pacing modes are used in atrial

and demand pacing. In each case, pacing and sensing only

occur in the atrium (AAI) or the ventricle (VVI).

The basic interval is started by a sense or pace event. If the

sense event occurs before the basic interval has expired, pacing

is inhibited. Otherwise, pacing occurs at the end of the basic

interval.

2.1.8 AOO, VOO

In these modes, atrial, ventricular and AV sequential pulses,

respectively, are emitted asynchronously.

These modes

primarily serve diagnostic purposes during follow-up. When

programming to the VOO or VOO mode, the risks associated

with asynchronous ventricular pacing should be considered.

2.1.9 DOO

Asynchronous, AV sequential pacing pulses are emitted in this

pacing mode. When programming DOO mode, the risks of

asynchronous ventricular pacing should be considered.

2.1.10 VDI

The VDI mode corresponds to the VVI mode, with the additional

function of providing atrial sensing. However, the timing is the

same as the VVI mode. The purpose of the VDI mode is to

permit the use of the marker function with the IEGM for the atrial

channel, for example, to measure the retrograde conduction

time.

The VA conduction time between a ventricular pace or sense

event (with marker) and the atrial sense event can be measured

directly on the display or printout from the programmer or on an

ECG strip chart recorder (IEGM/marker output function).

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Stratos LV/LV-T Technical Manual 69

2.1.11 OFF (ODO)

In this mode, pacing and sensing functions are off. The OFF

mode is used to determine and evaluate the morphology of an

intrinsic rhythm. With external pulse control, the OFF mode is

used for electrophysiological studies. The OFF mode can be

programmed temporarily.

CAUTION

OFF Mode – The OFF mode can be transmitted as a

temporary program only to permit evaluation of the patient’s

spontaneous rhythm. (see Section 2.1.11).

2.2

Biventricular Synchronization of the

Stratos CRT-Ps

For the Stratos CRT-Ps, there are 2 possible settings for the BiV

Sync parameter: OFF and BiV RV RV-T.

OFF - If the BiV sync parameter is set to OFF, the CRT-P

ignores the left-ventricular channel and functions like a

conventional dual-chamber pacemaker. Consequently, pacing is

not delivered into the left ventricle.

BiV RV RV-T - When set to "BiV RV RV-T" the device provides

biventricular pacing with sensing in the right ventricle and

triggering of a right ventricular sensing event in the left ventricle.

The biventricular synch settings can be activated together with

the DDD(R), DDI(R), VDD(R), and VVI(R) pacing modes.

CAUTION

Sensing – The Stratos CRT-Ps do not sense in the left

ventricle.

AV Conduction – In patients with intact AV conduction, the

intrinsic atrial tachycardia is conducted to the ventricle 1:1.

With the resynchronization mode activated, spontaneous rate

of the right ventricle mode is synchronized for a rate up to

200 ppm in the left ventricle. For this reason, biventricular

pacing mode should be turned OFF in such cases.

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70 Stratos LV/LV-T Technical Manual

During biventricular pacing in the Stratos CRT-Ps, the right

ventricle is paced first. Starting from the initially paced chamber

(RV), the intraventricular conduction time (VV delay) is

permanently set to 5 ms after a right ventricular sensed or paced

event.

NOTE:

While ventricular pacing and sensing events are

synchronized, synchronization does not occur during

ventricular extrasystoles.

The following table presents in detail the effects of the standard

pacing modes with the biventricular modes:

Table 19. Biventricular Pacing Modes

Biventricular Pacing Modes

(BiV RV RV/T)

RVs inhibits RVp

RVs triggers LVp

2.3

Timing Functions

The availability of parameters and parameter values is

determined by the software used for programming / interrogating

the CRT-Ps.

2.3.1 Basic Rate

The basic rate is the pacing rate in the absence of an intrinsic

rhythm and is programmable up to 180 ppm. The interval for the

basic rate is the time between two pacing pulses and is thus

called the basic interval.

The basic rate is programmable:

32… (1)…60… (1)…88… (2)…122… (3)…140… (5)…180 ppm.

In atrial-controlled modes, the basic interval is started by an

atrial event. In atrial-controlled, dual-chamber modes, the basic

interval is also started by a ventricular extrasystole.

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Stratos LV/LV-T Technical Manual 71

In the ventricular-controlled modes, the basic interval is started

by a ventricular event.

CAUTION

Programming Modifications

changes should only be made after careful clinical

assessment. Clinical judgment should be used when

–

Extreme programming

programming permanent pacing rates below 40 ppm or above

100 ppm.

2.3.2 Rate Hysteresis

Rate Hysteresis can be programmed in DDD(R), DDT(R),

DDT(R)/A, DDI(R), VDD(R), VDT(R), VDI(R), VVI(R), VVT(R),

AAI(R) and AAT(R) modes. Hysteresis can be programmed

OFF or to values as low as -50 bpm. The Hysteresis rate is

based on the lower rate and the value of the programmable

parameter. Hysteresis is initiated by a sensed event. The

resulting Hysteresis rate is always less than the lower rate. A

conflict symbol (>>) will appear and transmission will be

prohibited for Hysteresis rates which are less than 30 bpm. The

ability to decrease the effective lower rate through Hysteresis is

intended to preserve intrinsic rhythm. The Stratos CRT-Ps

operate by waiting for a sensed event throughout the effective

lower rate interval (Hysteresis interval). If no sensed event

occurs, a pacing pulse is emitted following the Hysteresis

interval.

In DDD(R), DDT(R)/A, DDT(R), VDD(R), VDT(R), AAT(R) and

AAI(R) pacing modes, the hysteresis interval starts with an atrial

sense event. In DDI(R), VVI(R), VVT(R) and VDI(R) pacing

modes, the hysteresis interval starts with a ventricular sense

event. In DDD(R), DDT(R)/A, DDT(R), VDD(R) and VDT(R)

pacing modes, the hysteresis interval also starts with ventricular

extrasystoles.

NOTE:

If rate adaptation is active, the Hysteresis rate is based on

the current sensor-indicated rate and the value of the

programmable parameter.

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72 Stratos LV/LV-T Technical Manual

The rate hysteresis is deactivated in the standard setting, but

can be programmed from -5… (-5) … -90.

If Hysteresis is used in the DDI mode, the AV delay must be

programmed shorter than the spontaneous AV conduction time.

Otherwise, stimulation in the absence of spontaneous activity

occurs at the hysteresis rate instead of the lower rate.

Hysteresis is suspended during the Night Mode activated time.

Programming conflicts arise when the total decrease in rate is

below 30 ppm. Care should be exercised to avoid programming

a Night Mode rate and hysteresis that is below what is

appropriate and may be tolerated by the individual patient.

2.3.3 Scan Hysteresis

Scan hysteresis is expanded programmability of the Hysteresis

feature. Scan hysteresis searches for an underlying intrinsic

cardiac rhythm, which exists slightly below the programmed

lower rate (or sensor-indicated rate) of the CRT-P. Following

180 consecutive paced events, the stimulation rate is temporarily

decreased to the hysteresis rate for a programmed number of

beats. If a cardiac rhythm is not detected within the programmed

number of beats at the hysteresis rate, the stimulation rate

returns back to the original lower rate (or sensor-indicated rate).

Several programmable beat intervals are available to allow a

greater probability of detecting a spontaneous rhythm.

If an intrinsic cardiac rhythm is detected within the programmed

number of beats between the hysteresis rate and the lower rate,

the intrinsic rhythm is allowed and the CRT-P inhibits pacing.

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Stratos LV/LV-T Technical Manual 73

Figure 3. Scan Hysteresis

Scan hysteresis has been incorporated to promote intrinsic

cardiac rhythm and may reduce device energy consumption.

The number of scan interval is programmable, OFF, 1…(1)…15

cycles.

NOTES:

Scan Hysteresis is not active during the programmed Night

Mode.

Scan Hysteresis is only available when Hysteresis is

selected on.

Magnet application (closing of reed switch) suspends 180

consecutive event counter independent of the magnet effect.

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74 Stratos LV/LV-T Technical Manual

2.3.4 Repetitive Hysteresis

Repetitive hysteresis is expanded programmability of the

Hysteresis feature.

Repetitive hysteresis searches for an

underlying intrinsic cardiac rhythm, which may exist slightly

below the programmed lower rate (or sensor-indicated rate) of

the patient. Following 180 consecutive sensed events, this

feature allows the intrinsic rhythm to drop to or below the

hysteresis rate. During the time when the intrinsic rate is at or

below the hysteresis rate, pacing occurs at the hysteresis rate

for the programmed number of beats (up to 10). Should the

number of programmed beats be exceeded, the stimulation rate

returns to the lower rate (or sensor-indicated rate).

If an intrinsic cardiac rhythm is detected within the programmed

number of beats between the hysteresis rate and the lower rate,

the intrinsic rhythm is allowed and inhibits pacing by the CRT-P.

Figure 4. Repetitive Hysteresis

Repetitive hysteresis has been incorporated to promote

spontaneous cardiac rhythm and may reduce device energy

consumption.

NOTES:

Repetitive Hysteresis is not active during the programmed

Night Mode.

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Stratos LV/LV-T Technical Manual 75

Repetitive Hysteresis is only available when Hysteresis is

selected on.

Magnet application (closing of reed switch) suspends 180

consecutive event counter independent of synchronous or

asynchronous magnet effect.

There is one Standard Hysteresis interval which occurs

before the programmable number of Repetitive Hysteresis

occurs.

The repetitive rate hysteresis is deactivated in the standard

setting, but can be programmed to 1… (1) …15 cycles.

2.3.5 Night Mode

Programmable Night Time Begin and End in 10 minute steps.

The Night Mode feature allows a temporary reduction of the

base rate during normal sleeping hours. If selected, the base

rate is gradually and temporarily reduced to the programmed

night pacing rate. At the end of night mode, the base rate

gradually returns to the original values.

The Night Mode feature has been incorporated to allow the

patients spontaneous night rhythm and may reduce pulse

generator energy consumption.

NOTES:

Over time, the Stratos CRT-Ps internal time-of-day clock

may exhibit a discrepancy with the actual time (less than 1

hour per year).

This may cause a corresponding

discrepancy between the programmed sleep and wake times

and the actual times that the system changes the rate.

The programmer automatically updates the CRT-P time-

of-day clock each time the device is programmed.

The actual time when the respective increase or decrease in

rate occurs may begin up to 4 minutes after the programmed

time because of internal device timing.

The rate (ppm/s) at which Night Mode decreases and

increases is a function of the Sensor Gain decrease and

increase parameters.

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76 Stratos LV/LV-T Technical Manual

2.3.6 Refractory Periods

Sensed events that occur during the refractory period have no

effect on pacemaker timing. These atrial or ventricular sensed

events are classified as “unused” for normal CRT-P timing.

In the Stratos CRT-Ps, the total atrial refractory period has been

subdivided into an atrial refractory period (ARP), atrial far-field

protection (FFP) and a PMT protection window (PMT). In terms

of priority FFP is first, ARP second and PMT third.

When mode switching is turned ON, the atrial events in the atrial

refractory period and the PMT protection window are used as the

criteria in order to sense atrial tachyarrhythmias and to ensure

high atrial rates are not transmitted to the ventricle.

The behavior of BIOTRONIK CRT-Ps reacts differently

depending on the timing interval in which the atrial event occurs.

The behavior is summarized in Table 20.

Table 20. Response to Atrial Sense Events in Different

Timing Intervals in Stratos CRT-Ps

Timing Interval

A_soccurs during

the far-field

Response

No consequence. A_sis ignored (unused).

Neither the AV delay nor the ARP is

started. There is no influence on mode

switching.

protection (FFP)

A_soccurs during

the Atrial

The event influences mode switching.

Refractory

Period (ARP)

A_soccurs in the

PMT protection

window

The AUI (atrial upper interval) starts. The

AV delay is not restarted. Post-AES

pacing is started if the atrial sense is

classified as an AES.

2.3.6.1 Atrial Refractory Period

In all modes in which atrial depolarization can be sensed, the

Stratos CRT-Ps will start an atrial refractory period upon each

atrial depolarization (programmable: AUTO, 225…(25)…775). In

standard “Auto” setting, the atrial refractory period (ARP) is

automatically preset to a minimum value of 225 ms and is

automatically extended if the AV delay is longer.

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Stratos LV/LV-T Technical Manual 77

In the case an atrial sense event falls within the PMT protection

window, the Stratos CRT-Ps start a minimal ARP.

2.3.6.2 Atrial Far-Field Protection

In all dual chamber modes with atrial sensing, the

Stratos CRT-Ps start an atrial FFP window upon each ventricular

event to prevent sensing of far-field potentials in the ventricle.

The atrial far-field protection window is separately programmable

for ventricular sensed events at 30…(10)…100…(1)…200 ms

and for ventricular paced events at 30…(10)…100 and

100…(10)…220 ms. If an atrial event occurs during the FFP

window, the atrial event is classified as an invalid FFP event and

has no influence on the timing of the CRT-P.

With ventricular events (right ventricular sensed or paced, left

ventricular paced, VES), the Stratos CRT-Ps start an FFP

interval.

2.3.7 Atrial PMT Protection

In all atrial-controlled dual-chamber modes, Stratos CRT-Ps start

the PMT protection interval after each ventricular stimulus. This

prevents

retrograde

conduction

and

triggering

pacemaker-mediated tachycardias (PMTs). Right ventricular

extrasystoles begin an extended PMT interval.

In all dual-chamber modes controlled by the ventricle, the

Stratos CRT-Ps start the PMT protection interval after each initial

(right or left) ventricular event.

The PMT protection interval after a Vp is freely programmable,

while the PMT interval after VES is automatically set to 225 ms

greater than the PMT interval after Vp (Nominal value: 250 ms/

AUTO (175…(5)…600 ms).

If an atrial event occurs within the atrial PMT protection interval,

the atrial event is classified such that the AV delay is not

restarted.

In the Stratos CRT-Ps, the PMT protection interval is started with

a right or left ventricular paced event.

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78 Stratos LV/LV-T Technical Manual

2.3.8 Ventricular Refractory Period

In all modes in which a ventricular depolarization can be sensed,

the Stratos CRT-Ps begin a ventricular refractory period after

each ventricular event, using a standard value of 250 ms

(programmable as 150…(35)…500 ms).

2.3.9 AV Delay

2.3.9.1 Dynamic AV Delay

Programmable values

Lower AV limit:

Nominal value: 60 ppm, (30…(10)…180 ppm)

Upper AV limit:

Nominal value: 130 ppm, (30…(10)…180 ppm)

AV Interval Length for Low Rate:

Standard value: 150 ms (programmable 15… (5) …300 ms)

The AV delay defines the interval between an atrial paced or

sensed event and the ventricular pacing pulse. The AV delay

can be dynamically programmed in DDD(R), DDT(R)A and

VDD(R) modes. In all other mode the AV delay is a fixed value.

If the CRT-P is programmed to a dual chamber sensing mode,

an intrinsic ventricular event falling within the AV delay will inhibit

the ventricular pacing pulse. If not contraindicated, a longer AV

delay can be selected to increase the probability of ventricular

output pulse inhibition. Short AV delays are available for testing

purposes or if ventricular pre-excitation is desired (i.e.,

hemodynamic considerations). When the dynamic AV delays

are programmed, the dynamics are calculated from the

difference between two atrial sense events (As or Ap).

Dynamic AV Delay provides independent selection of AV Delays

from five rate ranges at pre-set AV Delay values. In addition, the

AV Delay after atrial pace events can be differentiated from the

AV interval after atrial sense events for dual chamber pacing

modes.

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Stratos LV/LV-T Technical Manual 79

The Dynamic AV Delay is intended to mimic the physiologic,

catecholamine-induced shortening of the AV Delay with

increasing

rate.

also

serves

for

automatic

prevention/termination of “circus movement” pacemaker

mediated tachycardia and for prevention of reentrant

supraventricular tachycardia (see PMT Management section).

2.3.9.2 AV Hysteresis

AV Hysteresis allows a user-programmable change in AV delay

that is designed to encourage normal conduction of intrinsic

signals from the atrium into the ventricles. An AV hysteresis

interval can be programmed OFF or a value range of

10…(10)…1000. With AV hysteresis enabled, the AV delay is

extended by a defined time value after sensing a ventricular

event. The long AV interval is used as long as intrinsic

ventricular activity is detected. The programmed short AV delay

interval resumes after a ventricular paced event.

CAUTION

AV Hysteresis – If the AV hysteresis is enabled along with

the algorithm for recognizing and terminating PMTs (PMT

management), the AV delay for recognizing and terminating a

PMT has a higher priority than the AV hysteresis.

2.3.9.3 AV Repetitive Hysteresis

With AV Repetitive Hysteresis, the AV delay is extended by a

defined hysteresis value after sensing an intrinsic ventricular

event. When a ventricular stimulated event occurs, a long AV

delay is used for the programmed number of cycles. (OFF;

1…(1)…10 cycles). If an intrinsic rhythm occurs during one of

the repetitive cycles, the long duration AV delay interval remains

in effect. If an intrinsic rhythm does not occur during the

repetitive cycles, the original AV delay interval resumes.

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80 Stratos LV/LV-T Technical Manual

2.3.9.4

AV Scan Hysteresis

With AV Scan Hysteresis enabled, after 180 consecutive pacing

cycles, the AV delay is extended for the programmed number of

pacing cycles (OFF; 1…(1)…10 cycles). If an intrinsic rhythm is

detected within the extended AV delay and the longer AV delay

remains in effect. If an intrinsic rhythm is not detected within the

number of scan cycles, the original AV delay value resumes.

2.3.10 VES Discrimination after Atrial Sensed

Events

Stratos CRT-Ps have a special timing interval (VES/As) – VES

discrimination after atrial sense events to identify ventricular

extrasystoles.

With each As, a VES discrimination interval is started in the

ventricle. If a ventricular sensed event occurs within the

discrimination interval, this event is interpreted as a Vs

(ventricular sensed event), and no extended PMT protection

interval is started.

In the factory setting, the VES discrimination after As is set to

350 ms (programmable: OFF, 250 …(5)… 450 ms).

VES/As terminates with each ventricular event.

The

If a ventricular event does not fall within the AV delay or the VES

discrimination interval, it is classified as a VES. A ventricular

event that is sensed within the VES discrimination interval, but

outside the AVE delay, starts a VA delay after which an atrial

paced is delivered.

2.3.11 Sense Compensation

For hemodynamic reasons, it is desirable to keep constant time

between an atrial and a ventricular contraction such that

physiological conditions are attained. To this end, the AV delay

after atrial sensing can be shortened by sense compensation.

For sense compensation, the values are programmable from

OFF, -10…(-10)…-120 ms (standard valued -50 ms). The AV

delay after an atrial sensing event is shorter by the programmed

value after pacing. The AV delay after atrial pacing then

corresponds to the programmed AV delay.

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Stratos LV/LV-T Technical Manual 81

2.3.12 Ventricular Blanking Period

The ventricular blanking time is the period after an atrial pacing

pulse during which ventricular sensing is deactivated. It is

intended to prevent ventricular sensing of the atrial pacing pulse

(“crosstalk”).

The blanking time shall be as short as possible in order to

provide ventricular sensing when a ventricular depolarization

could occur.

Crosstalk may be encountered if a shorter blanking time,

unipolar ventricular sensing, a higher ventricular sensitivity

(lower value) and/or a high atrial pulse amplitude and pulse

width are programmed.

Values between 30 ms and 70ms (30… (10) …70 ms) can be

set for the ventricular blanking period. The value should be set

as low as possible and yet high enough to ensure ventricular

sensing.

However, it must be programmed to ensure atrial pacing is not

sensed in the ventricle.

2.3.13 Safety AV Delay

The safety AV delay (set at 100 ms) applies to all dual chamber

pacing modes

To prevent ventricular pulse inhibition in the presence of

crosstalk, a ventricular pulse will be emitted at the end of the

safety AV delay (Figure 5). When pacing is AV sequential at the

pre-set safety AV delay, the presence of crosstalk should be

considered and appropriate reprogramming performed (lengthen

the ventricular blanking time, lower ventricular sensitivity, bipolar

configuration, and/or lower atrial pulse energy).

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82 Stratos LV/LV-T Technical Manual

Figure 5. Ventricular blanking time and safety AV

2.4

Pacing and Sensing Functions

2.4.1 Pulse Amplitude and Pulse Width

The pulse amplitude and pulse width can be independently

programmed for all three channels of the Stratos CRT-Ps.

The programmed pulse amplitude determines the voltage

applied to the heart during each pacing pulse. The pulse

amplitude is independently programmable for the atrial and

ventricular channels up to 7.2 volts. The pulse amplitude

remains consistent throughout the service life of the CRT-Ps.

The pacing safety margin is therefore not reduced by a decrease

in the CRT-P's battery voltage.

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Stratos LV/LV-T Technical Manual 83

CAUTION

Pulse Amplitude – Programming of pulse amplitudes, higher

than 4.8 V, in combination with long pulse widths and/or high

pacing rates can lead to premature activation of the

replacement indicator. If a pulse amplitude of 7.2 V or higher

is programmed and high pacing rates are reached, output

amplitudes may differ from programmed values.

Programming Modifications

changes should only be made after careful clinical

assessment. Clinical judgment should be used when

–

Extreme programming

programming permanent pacing rates below 40 ppm or above

100 ppm.

2.4.2 Sensitivity

The parameter “sensitivity” is used to set the pulse generator’s

threshold for detecting intracardiac signals. The lower the

programmed sensitivity values the higher the device’s sensitivity.

If intracardiac signals are of low amplitude, a change to a higher

sensitivity (lower value) may be indicated. Conversely, if the

sensing amplifier is responding to extraneous signals, such as

artifacts or interference, a change to a lower sensitivity (higher

value) may resolve the difficulty. In dual chamber sensing

modes, the sensitivity values for the atrial and ventricular

channels are independently programmable. With Unipolar

programming, the highest possible sensitivity setting is 1.0 mV.

2.4.3 Lead Polarity

The programmed lead polarity determines whether the CRT-P

senses or paces in a unipolar or bipolar configuration. Lead

polarity can be programmed separately for sensing and pacing

in all three chambers.

CAUTION

Atrial Sensitivity – In dual chamber systems, the atrial

sensitivity of 0.1 mV should only be programmed in

conjunction with a bipolar lead configuration.

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84 Stratos LV/LV-T Technical Manual

The Stratos CRT-Ps have a specially designed header that

allows the CRT-Ps to simultaneously sense and pace in both the

right and left ventricles. Biventricular pacing therapy requires

programming of a bipolar pacing configuration in the ventricle.

Refer to Section 8.1 for a summary of the sensing and pacing

configurations in the ventricle.

If a bipolar lead is connected to the CRT-P, unipolar or bipolar

configuration can be programmed for pacing and sensing. As

compared to bipolar pacing, the unipolar pacing pulse has the

advantage of being clearly identifiable on the ECG. Unipolar

pacing occasionally results in muscle stimulation in the device

pocket or diaphragm.

2.5

Automatic Lead Check

When Lead Check is activated, the lead impedance is

automatically measured with every pace. If the impedance

values are consecutively greater or less than the limits (<200 Ω

and >3000 Ω) for repeated measurements, the system

automatically switches from bipolar to

unipolar lead

configuration. A bipolar lead failure is verified if the lead

impedance measurement falls outside of the acceptable range

for three consecutive readings. When a lead failure has been

detected, a message is displayed on the programmer screen at

the next follow-up visit in order to notify the physician of the

change.

Lead Check also may be activated with unipolar leads. The

pass-fail criterion remains the same as with bipolar leads. In the

event that a lead failure occurs, the Lead Check feature is

disabled and a message is displayed on the programmer screen

at the next follow-up visit to notify the physician of the lead

status.

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Stratos LV/LV-T Technical Manual 85

CAUTION

Lead Check – Lead check will not lead to disabling of cardiac

resynchronization therapy. It limits the use of the

resynchronization features.

1. Lead check is possible only when the right ventricle is

paced first.

2. Lead check works only when the pacing voltages are

programmed between 2.4 and 4.8 V. The lead check

feature can be programmed OFF in patients that

require cardiac resynchronization therapy.

Care should be taken when programming Stratos CRT-Ps

with Lead Check ON as the device may switch from bipolar to

unipolar pacing and sensing without warning. This situation

may be inappropriate when using a Stratos CRT-P for patients

with an Implantable Cardioverter Defibrillator (ICD). The

following associated message appears when programming

this feature:

“Lead check may result in a switch to unipolar pacing and

sensing, which may be inappropriate for patients with an

ICD.”

Additionally, Lead Check should be programmed OFF before

lead connection as the feature will automatically reprogram

the device to unipolar in the absence of a lead.

Lead Check is temporarily suspended during magnet application

and is inactive during ERI.

NOTE:

In the Stratos CRT-Ps, an automatic lead check cannot be

programmed ON if left ventricular paces are programmed to

occur before right ventricular paces.

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86 Stratos LV/LV-T Technical Manual

2.6

Antitachycardia Functions:

The antitachycardia functions include:

•

Upper basic rate

Tachycardia mode

Tachycardia behavior

Mode Switching

PMT Management

Preventive Overdrive Pacing

Post-AES Pacing

2.6.1 Upper Rate and UTR Response

In atrial-controlled dual chamber modes, the upper tracking

interval (UTI), along with the atrial refractory period or PMT

protection window limits the ventricular pacing rate such that it

will never exceed the programmed upper rate regardless of the

patient's atrial rate.

In all triggered modes, the upper tracking interval limits the

pacing rate that is triggered by sensing.

NOTE:

Select the upper rate based upon the patient’s tolerance for

the rate. The upper rate limit determines the minimal interval

between a sense or pace event and the subsequent atrial or

ventricular pacing event. A shortening of the pacing interval

to the upper rate interval may also be initiated at rest (e.g.,

by detection of muscle potentials). Therefore, for patients

with increased vulnerability a lower programmed upper rate

is recommended.

2.7

Wenckebach 2:1

Wenckebach behavior or 2:1 behavior is available depending on

the programming of the atrial refractory period, the PMT

protection window and the upper tracking interval in the modes

DDD, DDT/A, VDD, DDT and VDT.

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Stratos LV/LV-T Technical Manual 87

Wenckebach Behavior

If the end of the AV delay falls within the upper threshold rate

interval, ventricular pacing occurs at the end of the upper

tracking interval.

2:1 Behavior

If the high-rate atrial event occurs in the ARP, the FFP or PMT

protection window, an AV delay is not started.

In Wenckebach mode, the CRT-P switches to ventricular timing.

This means that a VA delay is started after a ventricular event to

avoid the atrial basic interval extend the duration of the

Wenckebach mode. The VA delay is calculated from the basic

(hysteresis) interval minus the AV delay (or the AV safety

interval).

The timing of the Stratos CRT-Ps ensures that the ventricular

paced event (Vp) following the VA delay allows atrial pacing at

the end of the AV delay; thus, terminating the Wenckebach

cycle.

The CRT-P counts the number of Wenckebach cycles. In more

than four Wenckebach cycles are detected, a shortened VA

delay is started after a right or left ventricular paced event to

guarantee constancy of the ventricular rate. The short VA delay

is in this instance calculated from the ventricular interval of the

upper tacking interval minus the AV delay (or the AV safety

interval). If the Wenckebach mode has been terminated, the

counter of the CRT-P is reset.

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88 Stratos LV/LV-T Technical Manual

2.8

Mode Switching

Mode switching prevents the conduction of paroxysmal

atrial tachycardias to the ventricle. Therefore, after sensing

an atrial tachycardia while in activated mode switching, the

CRT-P automatically switches to an atrial-controlled R-

mode. Like the programmed atrial-controlled P-mode, the

corresponding R-modes can be programmed:

Table 21. Mode Switching

Programmed P mode

Programmed R mode in case of

sensed atrial tachycardias

DDD

DDI

DDD

DDDR

VDD

DDIR

VDI

VDD

VDIR

DDI

DDIR

VDDR

DDTA

DDTAR

The Mode Switching algorithm causes the CRT-P to change

pacing modes when a programmed number of atrial intervals

(X) out of 8 consecutive atrial intervals (p-p) are faster than the

programmed mode switch intervention rate (X out of 8). X is

programmable from 3 to 8. The rate at which an atrial interval is

determined to signify an atrial tachyarrhythmia is called the

mode switch intervention rate. The mode switch intervention

rate is programmable from 100…(10)…250 bpm.

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Stratos LV/LV-T Technical Manual 89

Reversion back to the programmed pacing mode occurs in a

similarly programmable manner. If a programmable number of

atrial intervals (Z) out of 8 consecutive atrial intervals (p-p) are

slower than the programmed mode switch intervention rate

(Z out of 8), the device will revert back to the permanently

programmed parameters. Z is programmable from 3 to 8. The

device will also revert back to the permanent program if 2

atrial-paced events occur or if no atrial paced or sensed events

have occurred for at least 2 seconds. Each occurrence of mode

switching resets the corresponding counter (X or Z) to a value of

zero.

Mode Switch Events are recorded in memory and are

available to the user through the following diagnostics:

•

IEGM Recordings

Tachy Episode Trends

Mode Switch Trends

Mode Switch Histogram

Mode Switch Counter

Mode Switching is temporarily suspended during magnet

application and are inactive during ERI.

2.9

PMT Management

A PMT is defined as a tachycardia caused by inadvertently

tracking the retrograde P-waves. The PMT management feature

includes PMT Protection/Termination and a programmable PMT

detection and termination algorithm.

2.9.1 Protection

Pacemaker-mediated tachycardia (PMT) is normally triggered by

ventricular depolarizations that are not synchronized with atrial

depolarizations (e.g., VES). The tachycardia is maintained in a

retrograde direction by intrinsic VA conduction of the stimulated

ventricular depolarization and in an antegrade direction by

ventricular pacing of the pacemaker that is triggered by P-waves.

It is the objective of the atrial PMT protection interval to not use

retrogradely conducted atrial sensed events for pacemaker

timing, but only to statistically evaluate them for detection of

atrial tachycardia incidents.

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90 Stratos LV/LV-T Technical Manual

To prevent occurrence of a PMT, Stratos CRT-Ps start an atrial

PMT protection interval after each ventricular paced event (right

or left). If an atrial even is sensed within this PMT protection

interval, this will neither start an AV delay nor a basic interval.

The length of the PMT protection can be set to automatic (Auto).

In this case, the PMT protection window can be automatically

extended after the PMT is detected and terminated.

NOTE:

The initial values of the PMT protection interval in the

automatic setting at 175 ms after a Vp, and 400 ms after

VES.

2.9.2 PMT Detection

It is the objective of PMT detection to identify ongoing PMTs, to

distinguish them from the sinus rhythm and to terminate them.

The detection of a PMT starts by measuring the Vp-As intervals.

If these lie below the programmable PMT VA criterion

(programming depends on the retrograde conduction time of the

patient), the measurement of the stability of the Vp-As interval is

started.

The Stratos CRT-P’s PMT detection/termination algorithm

consists of suspicion, confirmation and termination components

and is described as follows.

Suspicion

A PMT is suspected when two criteria are met:

•

8 successive V pace-A sense (Vp-As) sequences have

occurred with a length shorter than the VA criterion.

This VA criterion is programmable between 250 and 500

ms.

•

The mean deviation of these 8 Vp-As intervals is less

than the Stability criterion parameter, defined with

respect to upper and lower values is ±25 ms.

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Stratos LV/LV-T Technical Manual 91

Confirmation

When the suspicion criterion has been met, the Stratos CRT-Ps

slightly modify the AV delay interval (+ or - 50 ms) for one

cardiac cycle. If the Vp-As interval remains stable, a PMT is

confirmed. Otherwise, a PMT is not confirmed and the algorithm

restarts. Once the PMT algorithm has confirmed a PMT, the

cycle is terminated.

The upper interval limit range must be shorter than the limit of

the VA delay (350 ms, for example). The test method is based

on the length of the pacing interval or the AV delay (refer to

Table 22).

Table 22. PMT Test Method

Interval Length

> UTI (upper

tracking interval)

AV Delay

≤ 200 ms

Test Method

Increasing the AV

delay by 50 ms

Reducing the AV

delay by 50 ms

Increasing the UTI

by 50 ms

Increasing the UTI

by 50 ms

Length of UTI = TA

+ 50 ms

> UTI + 50 ms

> 200 ms

≤ 200 ms

> 200 ms

≤ UTI

> UTI and ≤ UTI +

50 ms

Termination

Stratos CRT-Ps extend TARP (Total Atrial Refractory Period) for

one cycle to equal the V-V interval + 50 ms.

2.10 Adjustment of the PMT Protection

Window

The PMT protection window can be automatically adjusted. This

automatic adjustment functions in the following manner:

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92 Stratos LV/LV-T Technical Manual

When the PMT is detected and terminated, the PMT protection

interval is extended by 50 ms. If no additional PMTs arise within

two days, the length of the PMT protection interval is reduced by

another 50 ms. If additional PMTs occur, the PMT protection

interval is increased by another 50 ms. This occurs until no

more PMTs are detected. In the absence of PMTs, the PMT

protection interval is successively reduced. The initial values of

the PMT protection interval in the automatic setting at 175 ms

after Vp and 400 ms after VES.

2.11 Atrial Upper Rate

The atrial upper rate (AUR) prevents atrial pacing from occurring

in the vulnerable phase after an atrial sensed event during the

PMT protection interval, and ensures that the next atrial paced

event occurs after the heart’s natural atrial refractory period.

To avoid this, an atrial upper rate of 200 ppm (atrial upper

interval (AUI), 300 ms) is started after a PMT-As.

The next Ap can only be emitted after the expiration of the AUI.

When there are high sensor rates, the atrial pacing is shifted. To

guarantee stability of the ventricular rate, the AV delay is

shortened to no less than the safety interval when the basic

interval is lengthened.

NOTE:

Right atrial pacing does not occur when mode switching is

activated, and when the atrial upper rate is activated in DDI

mode at the end of the sensor or basic interval.

2.12 Preventive Overdrive Pacing

(Overdrive Mode)

The atrial pacing rate increases after each atrial sensed event

that is not classified as an atrial extrasystole, in an attempt to

suppress atrial tachyarrhythmias.

The overdrive algorithm

triggers atrial overdrive pacing and guarantees that pacing

occurs at a rate slightly above the intrinsic sinus rate. Atrial

overdrive pacing thereby minimizes the number of atrial sensed

events. The overdrive mode is available in modes DDD(R),

DDT/A(R), AAI(R) and AAT(R).

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Stratos LV/LV-T Technical Manual 93

The features of Atrial Overdrive pacing include:

After every atrial sensed event (non-AES), the pacing rate is

increased by a programmable rate increase above the last P-P

interval (2… (2)…10 ppm). If the intrinsic rate does not continue

to rise after the programmable number of cycles (overdrive

pacing plateau), the overdrive pacing rate is reduced in steps of

1 ppm. In each instance, the rate drop occurs after the

programmed number of cycles has been completed. Values

between 1 and 32 cycles can be assigned to the overdrive

pacing plateau.

The pacing rate is reduced until an atrial event is again sensed.

Afterwards, the overdrive pacing cycle begins again at an

increased rate.

Protection Function of the Algorithm

Preventive overdrive pacing (Overdrive Mode) consists of

different functions that become effective at high atrial rates:

•

When the programmed maximum overdrive rate (MOR,

standard setting 120 ppm, (90… (5)…160 ppm) is

exceeded as with atrial tachycardias, the algorithm is

automatically deactivated. If the rate falls below the

MOR, the overdrive algorithm is reactivated.

•

The function is deactivated when the mean of the atrial

rate over a period of twelve hours exceeds the average

safety rate (“overdrive average rate limit = OAR”). The

average safety rate is determined indirectly from the

maximum overdrive pacing rate (MOR minus 10ppm). If

the average safety rate is exceeded, the pacing rate is

incrementally reduced to the basic rate. If the average

atrial heart rate falls below the average safety rate, the

preventive

overdrive

pacing

reactivated

(activation/deactivation only in a 12 hour rhythm).

•

If the function is deactivated for a third time because the

average safety rate has been exceeded, overdrive

pacing remains OFF permanently. The overdrive mode

can not be reactivated until after the pacemaker has

been programmed.

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94 Stratos LV/LV-T Technical Manual

CAUTION

Overdrive Pacing Mode - When programming the overdrive

pacing mode, check whether the selected program can cause

PMT, and whether atrial over drive pacing would result.

Corresponding to the measured retrograde conduction time,

the PMT protection interval must be programmed to a correct

value.

2.13 AES Detection and Pacing

Post atrial extrasystoles (AES) pacing is intended to prevent the

occurrence of pro-arrhythmic long-short-long sequences due to

an atrial extrasystole, which can lead to atrial tachycardias. This

is achieved through a shortened post AES basic interval, which

is incrementally lengthened again during subsequent cycles until

the basic interval is attained.

The algorithm "Post AES Stimulation" is comprised of two parts.

First, an AES must be recognized (AES detection), and

secondly, the respective stimulation, Post AES Stimulation, must

then occur.

2.13.1 AES Detection

To detect atrial extrasystoles (AES), an "AES (timing) window" is

defined, the length of which is calculated from the averaging of

the rates of the four paced or intrinsic cardiac events prior to an

AES. The AES window is shortened by a programmable

percentage (5... (5) ...50%) from the averaged interval (nominal

setting is 25%). If an intrinsic atrial event falls within this AES

window and the coupling interval <750 ms, the cardiac event is

classified as an AES.

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Stratos LV/LV-T Technical Manual 95

2.13.2 Post AES Stimulation

The post AES stimulation (pacing) can be programmed for all

atrial-controlled modes (i.e., DDD(R), DDT/A(R), AAI(R) and

AAT(R). If an AES is detected, the pacemaker starts a "Post

AES Interval". The duration of the post-AES interval is equal to

the coupling interval of the Post-AES plus the "decrement step

size" (programmable 5 ... (5) ... 40 ppm). After the post AES

interval has expired, pacing occurs in the atrium. In each

subsequent cycle, the pacing rate is reduced by the value of the

"decrement step size" per stimulus until the basic rate (or sensor

rate) is again reached, or until the intrinsic cardiac rhythm takes

precedence again. The post AES stimulation is then concluded,

and it is repeated after each AES. The post-AES interval is never

shorter than the Upper Tracking Rate Interval (UTR).

Additionally, if the post-AES coupling interval is longer than the

current sensor rate, pacing occurs at the sensor rate.

NOTE:

When “preventative overdrive pacing” is activated, post-AES

pacing is not automatically activated. Both parameters can

be programmed independently of one another.

CAUTION

Post AES - Before activating post-AES, check whether the

selected program can cause Pacemaker Mediated

Tachycardia (PMT) and whether post-AES pacing results.

2.14 Parameters for Rate-Adaptive Pacing

2.14.1 Rate-Adaptation

The Stratos CRT-Ps are equipped with accelerometers that

located within the CRT-P. This sensor produces an electric

signal during physical activity of the patient. If a rate adaptive

mode is programmed, then the sensor signal controls the

stimulation rate. Sensing and inhibition remain in effect during

sensor controlled operation. In the case of high pacing rates,

however, the refractory periods may cover a majority of the lower

rate interval, resulting in asynchronous operation.

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96 Stratos LV/LV-T Technical Manual

The following diagnostic functions are available to tailor rate

adaptive pacing for the individual patient.

2.14.2 Sensor Gain

The sensor gain defines the slope of the linear function between

exertion and pacing rate. It designates a factor by which the

electric signal of the sensor is amplified prior to the signal

processing stages. The programmable amplification permits

adaptation of the individually programmed sensor gain to the

desired rate response. The optimum setting is achieved when

the desired maximum pacing rate during exertion is reached

during maximum exercise levels. The rate increase, rate

decrease and maximum sensor rate settings must be checked

for their suitability with respect to the individual patient before

adjusting the sensor gain.

If the sensor-driven rate is not sufficient at high levels of exertion

the sensor gain setting should be increased. The sensor gain

should be reduced if high pacing rates are obtained at low levels

of exertion (see Figure 6).

Figure 6 Influence of sensor gain on the rate response.

2.14.3 Automatic Sensor Gain

Stratos CRT-Ps offer an Automatic Sensor Gain setting, which

allows the physician to have the Sensor Gain parameter

adjusted automatically.

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Stratos LV/LV-T Technical Manual 97

When the Automatic Sensor Gain is activated, the CRT-P

samples the sensor-indicated rate. If, during the 24 hour period

beginning at midnight, the total time recorded at maximum

sensor rate exceeds 90 seconds, the sensor gain setting is

reduced by one step. The sensor gain will be increased by one

step if for 7 consecutive days; the time recorded at maximum

sensor rate is less than 90 seconds each day.

2.14.4 Sensor Threshold

The effects of rate adaptive pacing are limited to sensor signals

exceeding the programmable sensor threshold. Sensor signals

below this threshold do not affect rate response (Figure 7). The

programmable sensor threshold ensures that a stable rate at

rest can be achieved by ignoring sensor signals of low amplitude

that are not related to exertion.

If the pacing rate at rest is unstable, or tends to stay above the

lower rate without activity, the sensor threshold should be

increased. The sensor threshold should be reduced if a

sufficient rate increase is not observed at a given level of

exertion.

Figure 7 Effect of sensor threshold

2.14.5 Rate Increase

The rate increase parameter determines the maximum rate of

change in the pacing rate if the sensor signal indicates

increasing exertion.

The “rate attack” is set to standard value of 2 ppm/cycle and is

programmable (0.5; 1… (1)…6 ppm/cycle).

The programmed rate increase applies only to the

sensor-controlled operation and does not affect the rate changes

during atrial-controlled ventricular pacing.

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98 Stratos LV/LV-T Technical Manual

2.14.6 Maximum Activity Rate

Regardless of the sensor signal amplitude, the pacing rate

during sensor-driven operation will never exceed the

programmed maximum activity rate (MAR). The maximum

activity rate only limits the pacing rate during sensor-driven

operation and is independent of the rate limit. The rate increase

and rate decrease parameters are upper rate limited by the MAR

and lower rate limited by the basic rate (night rate) (MAR,

standard setting 120 ppm, programmable: 90 ppm… (5)

…180 ppm).

The pacing rate is determined by the highest rate from the

parameters of rate adaptation, the overdrive rate and the

post-AES rate.

2.14.7 Rate Decay

The “rate decay” is set to a standard value of 0.5 ppm/cycle and

is programmable (0.25… (0.25)…1.25 ppm/cycle).

The programmed rate decrease setting applies only to the

decrease in pacing rate during sensor-driven operation and does

not affect the pacing rate during atrial triggered ventricular

pacing.

2.15 Sensor Stimulation

Even when a non-rate adaptive mode is programmed, the

behavior of the sensor is recorded if a rate-adaptive mode has

been selected in the Mode Switching mode. The rate-adaptive

mode is only effective in Mode Switching.

The sensor

stimulation indicates how a sensor would have reacted with the

displayed sensor setting if a rate-adaptive mode had been

programmed.

This function is helpful to find the optimum sensor settings and to

compare the sensor rate with the intrinsic rate. When rate

adaptation is activated, sensor data are available that can be

used to evaluate the sensor behavior.

NOTE:

In the sensor stimulation, only values for the sensor

threshold that are greater than those used for the permanent

program maybe selected.

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Stratos LV/LV-T Technical Manual 99

2.16 Rate Fading

Rate Fading is intended to prevent a sudden drop in heart rate

when the Stratos CRT-Ps transition from tracking an intrinsic

rhythm to pacing due to an abrupt decrease in the intrinsic rate

or due to Mode Switching. This smooth drop in pacing rate is

designed to prevent symptoms such as dizziness, light

headedness, lack of energy and fainting spells. With Rate

Fading enabled, the Stratos CRT-Ps calculate a “Backup Rate”

that is always active in the background. As soon as the rate

decreases, the CRT-P begins pacing at the Backup Rate. The

Backup Rate corresponds to a delay of the intrinsic rate

corresponding to

programmable rate decrease; these parameters determine the

sensitivity of the controlled rate smoothing. After four

programmable rate increase and

consecutive intrinsic events (A_s– A_s), the CRT-P calculates the

Target Rate for the “Backup Rate”, which is a four beat average

of the intrinsic rate reduced by 10 ppm. The Target Rate cannot

exceed the Maximum Fading Rate (programmed as Max Activity

Rate) and cannot increase faster than the RF Rate Increase

(programmable in ppm/cycle).

When the intrinsic rate drops considerably (below the Target

Rate), the pacing rate drops to the Backup Rate and is then

decreased gradually by the programmable Decay Rate to the

Sensor Indicated Rate or Basic Rate. The Backup and Target

Rates are defined in Table 23.

If an atrial tachycardia occurs suddenly, triggering a mode

switch, the target rate is set to the sensor rate or basic rate. The

current pacing rate in the ventricle results from the current value

of the Target rate before the mode switching event.

If the pacing rate reaches the intrinsic rate during rate decay, at

least four consecutive intrinsic cycles above the pacing rate are

required before the pacing rate is once again adapted to the last

intrinsic event. Controlled rate smoothing is thereby continued

during intermittent sensed events.

The Rate Fading feature is suspended while in magnet mode

and disabled at ERI and in backup mode.

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100 Stratos LV/LV-T Technical Manual

Table 23. Backup and Target Rates

Feature

Description

Backup Rate

Rate that the CRT-P uses to pace when

there is a sudden rate decrease. This can

be a maximum of 10 ppm less than the

intrinsic rate and follows the Target Rate with

a 1 to 6 ppm per cycle increase or

0.25…1.25 ppm per cycle If the Target Rate

is less than the current Back Up Rate.

The Target Rate is either the current

detection rate minus 10 ppm, or the sensor

or basic rate. The Backup Rate follows the

Target Rate with the programmed rate

increase or decrease.

Target Rate

Figure 8: Rate Fading

2.17 Home Monitoring (Stratos LV-T)

Home Monitoring enables the exchange of information about a

patient’s cardiac status from the implant to the physician. Home

Monitoring can be used to provide the physician with advance

reports from the implant and can process them into graphical

and tabular format called a Cardio Report. This information

helps the physician optimize the therapy process, as it allows the

patient to be scheduled for additional clinical appointments

between regular follow-up visits if necessary.

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Stratos LV/LV-T Technical Manual 101

CAUTION

Patient’s Ability - Use of the Home Monitoring system

requires the patient and/or caregiver to follow the system

instructions and cooperate fully when transmitting data.

If the patient cannot understand or follow the instructions

because of physical or mental challenges, another adult who

can follow the instructions will be necessary for proper

transmission.

Electromagnetic Interference (EMI) – Precautions for EMI

interference with the Stratos CRT-Ps are provided in

Section 1.5.6. Sources of EMI including cellular telephones,

electronic article surveillance systems, and others are

discussed therein.

Use in Cellular Phone Restricted Areas - The mobile

patient device (transmitter/receiver) should not be utilized in

areas where cellular phones are restricted or prohibited (i.e.,

commercial aircraft).

Event Triggered Report - A timely receipt of the event report

cannot be guaranteed. The receipt is also dependent on

whether the patient was physically situated in the required

coverage range of the patient device at the time the event

information was sent.

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102 Stratos LV/LV-T Technical Manual

CAUTION

Patient-Activated Report - The magnet effect must be

programmed “synchronous” if the [Patient Report] function is

activated.

Not for Conclusive Diagnosis - Because not all information

available in the implant is being transmitted, the data

transmitted by Home Monitoring should be evaluated in

conjunction with other clinical indicators (i.e., in-office

follow-up, patient symptoms, etc.) in order to make a proper

diagnosis.

Frequency of Office Follow-Ups When Using Home

Monitoring - The use of Home Monitoring does not replace

regular follow-up examinations.

When using Home

Monitoring, the time period between follow-up visits may not

be extended.

The implant’s Home Monitoring functions can be used for the

entire operational life of the implant (prior to ERI) or for shorter

periods, such as several weeks or months.

NOTE:

When ERI mode is reached, this status is transmitted.

Further measurements and transmissions of Home

Monitoring data are no longer possible.

2.17.1 Transmission of Information

The implant transmits information with a small transmitter, which

has a range of about 6 feet (2 meters). The patient’s implant

data are sent to the corresponding patient device in configurable

periodic intervals. The transmissions may also be activated by

the patient with the application of a magnet over the implant and

by certain cardiac events, as programmed. The types of

transmissions are discussed in Section 2.17.4.

The minimal distance between the implant and the patient device

must be 6 inches (15 cm).

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Stratos LV/LV-T Technical Manual 103

2.17.2 Patient Device

The patient device (Figure 9) is designed for use in or away

from the home and is comprised of the mobile unit and the

associated charging station. The patient can carry the mobile

unit during his or her occupational and leisure activities. The

patient device is rechargeable, allowing for an approximate

operational time of 24 hours. It receives information from the

implant and forwards it via the cellular mobile network or the

standard telephone system to a BIOTRONIK Service Center.

For additional information about the patient device, please refer

to its manual.

2.17.3 Transmitting Data

The implant’s information is digitally formatted by the

BIOTRONIK Service Center and processed into a concise report

called a Cardio Report. The Cardio Report, which is adjusted to

the individual needs of the patient, contains current and previous

implant data. The Cardio Report is sent to the attending

physician via fax or is available on the Internet, which is selected

during registration of the patient. For more information on

registering for Home Monitoring, contact your BIOTRONIK sales

representative.

The password protected BIOTRONIK Home Monitoring website

can be accessed at the following URL:

www.biotronik-homemonitoring.com

An online help menu is available in order to assist with the use of

the Home Monitoring website.

Use of the Internet for reviewing Home Monitoring data must be

in conjunction with the system requirements listed in Table 24.

Additionally, Table 24 provides system specifications that are

recommended for optimizing usage of the Internet.

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104 Stratos LV/LV-T Technical Manual

Table 24: System Requirements / Recommendations

System

Requirements

Recommendations

(for Optimal Usage)

Screen

Resolution

Internet

Bandwidth

800 x 600

56 kB/sec

≥ 1024 x 768

≥ 128 kB/sec

(DSL, cable modem)

N/A

600 MHz, 128 MB

RAM

Internet

Browser

MS Internet

Explorer 5.0

- or -

≥ MS Internet

Explorer 5.5

- or -

Netscape

≥ Netscape 7/Mozilla

Navigator 4.72

Acrobat Reader Version 4

Version 5 or higher

Communication

Channel

Fax (G3) or e-mail

Fax (G3), e-mail or

mobile phone

Additionally, the attending physician may register to be informed

of the occurrence of an Event Triggered Message through email

or SMS (i.e., mobile phone) with a brief text message. If

registered for Internet availability, the patient’s detailed implant

data can then be viewed by logging onto the Home Monitoring

website.

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Stratos LV/LV-T Technical Manual 105

Figure 9: Example of Patient Device with Charging Stand

2.17.4 Types of Report Transmissions

When the Home Monitoring function is activated, the

transmission of a report (Cardio Report) from the implant can be

triggered as follows:

•

Trend report – the time period (daily) initiates the report

Event report – the pulse generator detects certain

events, which initiate a report

•

Patient report – the patient initiates the report

2.17.4.1 Trend Report

The time of the report transmission is programmable. For

periodic messages, the time can be set anywhere between 0:00

and 23:50 hours. It is recommended to select a time between

0:00 and 4:00.

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106 Stratos LV/LV-T Technical Manual

The length of the time interval (monitoring interval) is preset to

“daily”. For each monitoring interval, a data set is generated in

the implant and the transmission is initiated at the designated

time.

2.17.4.2 Event Report

When certain cardiac and technical events are detected by the

implant, a report transmission is automatically triggered. This is

described as an “event message”.

The following cardiac and technical events initiate a message

transmission:

•

Atrial

Lead

Check

•

Low P-Wave Amplitude*)

(<50% safety margin)

< 300 and > 3000 Ohm

Ventricular Lead Check

< 300 and > 3000 Ohm

Low R-Wave Amplitude*

(<50% safety margin)

ACC Disabled

Ventricular Threshold >4.8V

CAUTION

Event Triggered Report - A timely receipt of the event report

cannot be guaranteed. The receipt is also dependent on

whether the patient was physically situated in the required

coverage range of the patient device at the time the event

information was sent.

^*)Examples: The programmed sensitivity is 1.0 mV.

A) Average of the measured P/R-Wave amplitudes is 2.6 mV. Therefore,

measured value is greater than 100% of the safety margin. Event report is

not triggered.

B) Average of the measured P/R-Wave amplitudes is 1.9 mV. Therefore,

measured value is less than 100%, but greater than 50% of the safety

margin. Event report is not triggered.

C) Average of the measured P/R-Wave amplitudes is 1.4 mV. Therefore,

measured value is smaller than 50% of the safety margin. As a result, an

event report is triggered.

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Stratos LV/LV-T Technical Manual 107

NOTE:

The attending physician must notify the BIOTRONIK Service

Center about which of these events he/she wishes to be

informed.

2.17.4.3 Patient Report

It is possible to trigger a transmission through magnet

application over the CRT-P. The attending physician must

inform the patient in detail about operating the device and about

the physical symptoms which would warrant a magnet

application by the patient.

CAUTION

Patient-Activated Report - The magnet effect must be

programmed “synchronous” if the [Patient Report] function is

activated.

2.17.5 Description of Transmitted Data

The following data are transmitted by the Home Monitoring

system, when activated. In addition to the medical data, the

serial number of the implant is also transmitted.

The Monitoring Interval

Type of Last Home Monitoring Message and Time of the

Transmission of the last Home Monitoring Message provide

information regarding the interval of Home Monitoring data.

Resynchronization Therapy

•

% Pacing in the Atrium / 24 hours [%]

Atrial intrinsic rhythm [%]

CRT - %ventricular pacing [%]

Ventricular paces (AV Delay expired) [%]

Ventricular paces (triggered by RV Sense) [%]

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108 Stratos LV/LV-T Technical Manual

Heart Failure Diagnostics

•

Mean Ventricular Heart Rate [ppm]

Mean Ventricular Heart Rate at Rest [ppm]

VES / 24 Hour

Daily Activity (hours)

Number of Mode Switches / 24 hours

Duration of Mode Switching / 24 hours [%]

Ventricular Rhythm

•

Mean Ventricular Rate at Mode Switching [ppm]

Number of Ventricular Episodes (>8 consecutive VES)

Number of Ventricular Runs (4…8 consecutive VES)

PMTs Detected

AV Conduction

•

With Intrinsic Rhythm (As-Vs) [%]

With Atrial Stimulation (Ap-Vs) [%]

With Ventricular Stimulation (As-Vp) [%]

With Atrial and Ventricular Stimulation (Ap-Vp) [%]

Leads

•

Mean P-Wave amplitude [mV]

Mean R-Wave amplitude [mV]

Atrial Pacing Impedance [ohms]

Right Ventricular Pacing Impedance [ohms]

Left Ventricular Pacing Impedance [ohms]

System Status

•

Battery Voltage [V]

Battery Impedance [ohms]

Battery Status

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Stratos LV/LV-T Technical Manual 109

2.18 Statistics

Stratos CRT-Ps can store a variety of statistical information. The

various statistics consist of such features as rate histograms,

event counters, sensor trends, VES statistics, and activity

reports, which are described in the following sections.

2.18.1 Timing

•

Event Counters

Event Episodes

A / V Rate Histogram

A / V Rate Trend

2.18.2 Arrhythmia

•

Tachy Episode Trend

AF Classification

AES Classification

AES vs. Atrial Rate

VES Classification

VES versus ventricular rate

VES Coupling Intervals

2.18.3 Sensor

•

Rate / Sensor Trend

Sensor Rate Histogram

Activity Report

Sensor Optimization

2.18.4 Sensing

•

P-wave Trends

R-wave Trends

2.18.5 Pacing

•

A / V Impedance Trends

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110 Stratos LV/LV-T Technical Manual

2.18.6 General Statistical Information

•

The Stratos CRT-P’s statistics modes are always in

operation and cannot be selected OFF.

The counters within the statistic features do not operate

when a magnet is applied to the CRT-Ps

The counters within the statistic features are reset each

time the Stratos CRT-Ps are permanently programmed.

Event counters are displayed as bar charts showing the

event totals expressed as a percentage.

Histograms count how often events occur in different

time or rate intervals (for example, how many events

occurred in a 160 to 169 ppm range).

•

Trends represent a certain number of events at a fixed

point in time (e.g., rates). The trends are plotted as

points that are joined together by a curve. In the

Stratos CRT-Ps, the trends of the three different

channels are identified with different colors.

NOTE:

When a magnet is applied, Stratos CRT-Ps can only

continue recording diagnostic data when in the “synchronous

magnet mode or during the first 10 cycles of the “auto”

magnet mode.

2.19 Interrogating and/or Starting

Statistics

The recorded diagnostic data (saved data contents of the

pacemaker) are always read (transmitted through interrogation)

at the beginning of the follow-up and saved to the programmer.

This allows relevant data to be displayed on the programmer at

anytime.

All statistics can be reset with the “Clear Statistics” function and

the “Transmit” function in the “Parameter” selection menu. The

start time and duration are automatically saved for all statistics.

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Stratos LV/LV-T Technical Manual 111

2.20 Timing Statistics

2.20.1 Event Counter

The event counter totals all of the sensed and paced events

from all three channels. With the event counter, the

following events and event sequences can be registered

over several years:

•

Atrial: detection (As), detection during ARP (ARS), FFP

(As_FFP), and the PMT window (As_PMT), pacing (Ap)

•

Ventricular: RV sensing, RV pacing and LV pacing

Ventricular extrasystoles are counted both as VES and

as ventricular sense events.

NOTE:

All event counter data are transmitted to the programmer

and evaluated there, but not all events are displayed in detail

on the programmer.

Additionally, the Stratos CRT-Ps have a PMT counter and a

counter for safety power-down overdrive.

2.20.2 Event Episodes

In contrast to the event counter, it is not the individual

events, but rather the event sequences that are counted:

•

As followed by Vs

As followed by Vp

Ap followed by Vs

Ap followed by Vp

Vx followed by Vx

The event sequence V-V means two consecutive ventricular

events (sensing or pacing) without a previous atrial event.

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112 Stratos LV/LV-T Technical Manual

NOTE:

The VV value can deviate from the number of VES’ since the

Stratos CRT-Ps can also classify ventricular sensed events

that were preceded by an atrial event such as extrasystoles

via the AVES discrimination function after As.

In Stratos CRT-Ps:

•

RVs followed by LVp.

RVp followed by LVp

LVp followed by RVp

A total counter that records grand total of all conductions is

located below the conduction counters.

2.20.3 Rate Trend

The rate trend is displayed as a line chart and consists of the

heart rate trend and the pacing rate trend. The atrial event, the

ventricular events and the events in the remaining third channel

are recorded at a set time. In the rate trend, the heart rate in

pulses per minute (ppm) is recorded in the upper rate chart, and

the percentage of pacing is shown in the lower chart. In the

Stratos CRT-Ps, the trends of the three different channels are

identified by three different colors.

Please note that a gap in the trend will be displayed for the

duration of an asynchronous magnet program or temporary

program.

2.20.4 Atrial and Ventricular Rate Histogram

The Stratos CRT-Ps are provided with separate atrial and

ventricular histograms. A bar chart displays the heart rate as a

percentage and corresponding absolute value. The number of

times in which the heart rate occurs in specific ranges is

recorded separately according to sensing and pacing. The rate

range between 40 and 390 ppm is divided into 10 ppm

increments along a rate measuring axis. The distribution of

distribution of the heart rates can be displayed on the

programmer as a diagram during follow-up examinations.

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Stratos LV/LV-T Technical Manual 113

NOTE:

The bars of the histogram are standardized to a rate class

width of 10 ppm to avoid distortion of the rate distribution.

2.21 Arrhythmia Statistics

2.21.1 Tachy Episode Trend

The Tachy Episode trend can only be selected when Mode

Switching has been programmed ON and for events that occur

at less than 1 minute intervals are combined in the tachy episode

and stored.

In the tachy episode trend, each tachycardic mode switching

episode is recorded in the statistics table with its initial date and

time as well as its duration. This documents both the frequency

and length of the tachycardic periods which can be evaluated in

the follow-up.

Mode Switch Counter – A counter reports the number of mode

switches that occurred since the last follow-up visit.

Mode Switch Trend (Tachy Episode Protocol) - The trend

records up to 64 atrial tachycardia episodes that result in a mode

switch. The trends are available as a rolling trend and therefore

contain information about the most recent events. The atrial

tachycardia episodes are displayed graphically as a function of

time on the programmer screen.

NOTE:

When the elective replacement indication (ERI) has been

attained, the contents of the tachy episode trends as well as

all memory contents are “frozen” and further recording is

stopped.

2.21.2 AF Classification

To adequately record atrial fibrillation (AF) and reduce the

number of times the recording is turned ON and OFF, a lower

and upper AF detection rate can be set. Both the lower sensing

rate as well as well as the upper resolution rate is

programmable: (100… (10)…300…… (2)…400 ppm).

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114 Stratos LV/LV-T Technical Manual

In addition to the detection rate, an AF is classified using X-out-

of-8 algorithm of mode switching. If mode switching is not

programmed, the standard setting of 5-out-of-8 is used.

In the statistics, the AF duration (1 min, 10 min, 60 min 4 h, 12 h,

24 h, 48 h, > 48 h) as well as the AF start time (0-3 hours, 3-6

hours, 6-9 hours, 9-12 hours, 12-15 hours, 15-18 hours, 18-21

hours, 21-24 hours) are shown in the histograms.

2.21.3 AES Statistics

This function enables long-term recording and analysis of atrial

extrasystoles (AES events). An atrial event is classified as an

atrial extra systole (AES) if it falls in the AES window. This AES

window begins after the absolute atrial refractory period and

ends at a programmable Atrial Prematurity percentage of the

average of the last four P-P intervals.

AT/AES Classification

The Stratos CRT-Ps classify AES events that occur according to

their complexity. The following information is available when

AES statistics are enabled.

Class Corresponding to Additional Criteria

AFl

Atrial Fibrillation unstable rate and x out of 8 criteria

Atrial Flutter stable rate

Atrial Tachycardia

Sudden onset

Additionally, the following accelerations between zones are

reported.

AFl to AF

AT to AF

AT to AFl

SR to AT

The AES events are classified according to their complexity in

one of the following classes.

Class

Single

Event

AES

Sequence

A-AES

Couplets A-AES-AES

Triplets

A-AES-AES-AES

The average number of AES per hour and the shortest AES-AES

interval are also reported.

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AES vs. Atrial Rate

Information about the number of AES events as a function of the

atrial rate can be found in the AES vs Atrial Rate Histograms.

For Stratos CRT-Ps, single AES bar chart displays the

percentage of specific AES in 17 different rate ranges (< 40 ppm

to > 180 ppm). The atrial rate of the last interval before the AES

serves to classify the AES.

Two sequential AES are saved as a couplet, and three

sequential AES are saved as a triplet.

AES Coupling Interval

The AES coupling interval shows in which millisecond range the

prematurity (distance As/Ap to AES) has occurred. The intervals

of the AES-AES Sequences are displayed from < 200 to 1040

ms in 24 histograms classes. The graphic display shows the

percentage values if the individual classes in the form of a bar

chart and the total number of events.

2.21.4 VES Statistics

The detected VES are ventricular events outside of the AV delay

and the VER discrimination interval after As.

Therefore, it is recommended that the atrial sensing be stable

before activating the VES analysis. If the atrial lead is bipolar,

bipolar sensing should be considered.

The VER prematurity histogram is subdivided into three

percentage classes:

•

0-25% (premature VES-VES from 750 to 1000 ms at 60

ppm in the preceding interval).

25-50% (premature for VES-VES from 500 to 750 ms at

60 ppm in the preceding interval).

>50%(premature for VES-VES from < 500 ms at 60 ppm

in the preceding interval)

The VES sequence histogram also displays single VES’,

couplets, triplets, runs and VT episodes.

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VES Classification

VES vs. Ventricular rate

The VES versus the ventricular rate is likewise displayed in a

histogram with 16 equidistant classes of < 40 to 180 ppm. The

graphic display shows the percentage values of the individual

classes in the form of a bar chart and the total number of events.

Subsequent VES’ (couplets, triplets) are recorded as one event.

VES Coupling Interval

The VES coupling interval shows in which millisecond range the

prematurity has occurred. The intervals of the VES-VES

sequences are displayed from < 200 to 1040 ms in 24 histogram

classes. The graphic display shows the percentage values of

the individual classes in the form of a bar chart and the total

number of events.

In the case of subsequent VES’ (couplets, triplets), these are no

longer included. Only the first VES is classified.

2.22 Sensor Statistics

2.22.1 Sensor Rate Histogram

This function records how often the sensor rate is within in

certain ranges. The rate range is subdivided into 16 rate classes

going from 40 to 180, including bins for rates < 40 bpm and rates

>180 bpm. The percentage and total number of sensed and

paced events occurring within a rate class is displayed.

Sensor rate recording is independent of the effectiveness of the

respective pacing rate, and it is not influenced by inhibition of

pacing due to spontaneous events. Rate data are also recorded

in non-rate-adaptive modes.

Recording stops when the memory available for recording the

sensor rates is full. Recordings can be stored for several years.

The frequency distribution of the sensor rates can be displayed

as a diagram during follow-up examinations.

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2.22.2 Activity Report

This feature operates by recording characteristic pulse

generator data related to patient activity and pacing the

system. It is divided into three ranges:

•

No Activity

Activity

MAR (Maximum Activity Rate)

This data can assist in the analysis of heart and sensor activity.

For example, a high value for the activity may indicate that the

sensor gain is set too high. In contrast, an extremely low value

for activity may indicate that the sensor gain is too low. All

values are expressed as percentages.

2.22.3 Sensor Optimization

The sensor optimization is displayed in the form of a line graph

containing the length of the time intervals and the trend data.

The sensor parameters are simulated and displayed as a trend.

The thicker line represents the recorded (intrinsic) trend) and the

thinner line the simulated (sensor) trend. A movable cursor

simplifies the reading of the intrinsic and the sensor trends.

2.23 Sensing Statistics

P-Wave Trend

This is the display of the sensitivity course in the atrium. The

P-wave trend is displayed in the form of a line chart. This P-

wave trend is a rolling, long-term trend with the programmed

resolution of 45 s – 36 h. Therefore, the 240 time windows with

the 36 h recording periods result in actual recordings for

approximately one year.

The P-wave trend can record

amplitudes from 0.0 to 20 mV.

The trend is only displayed when sensed events are present.

During paced events, in the temporary program, or in the magnet

“asynchronous” mode, recordings are not made in the trend

(there are gaps).

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118 Stratos LV/LV-T Technical Manual

R-Wave Trend

This is the sensitivity of the ventricles displayed over time. The

R-wave trend is displayed in the form of a line chart. The R-

wave trend is a rolling, long-term trend with a fixed resolution of

36 hours. Therefore, the 240 time windows with 36 hour

recording periods result in actual recordings of approximately

one year. The R-wave trend can record amplitudes from 0.0 to

20 mV. In the Stratos LV, the specific RV and LV amplitudes are

shown in trends of different colors. The R-wave trend is

available in all modes that sense in the ventricle, except

triggered modes DDI(R)/T, DVT(R), VDT(R) and VVT(R).

2.24 Pacing Statistics

Impedance Trend

The atrial and ventricular impedances are measured in the

Stratos CRT-Ps and both values are displayed in the impedance

trend in the form of a line chart. The impedance trend is a

long-term trend with a fixed resolution of 36 hours per window.

Therefore, the 240 possible windows, each with 36 hour

recording periods, result in an actual recording time of

approximately one year. This recording only occurs in paced

events.

After approximately one year of recording, the impedance trend

begins to roll. The impedance can also be recorded in the left

atrial and left ventricular channel. The values of the impedance

trend lie between 0 to 10k Ω. The atrial and both ventricular

channels are shown as different colored trends.

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3. Follow-up Procedures

3.1

General Considerations

The CRT-P follow-up serves to verify appropriate function of the

pacing system, and to optimize the parameter settings.

In most instances, pacing system malfunction attributed to

causes such as chronic threshold can be corrected by

reprogramming the CRT-Ps.

The follow-up intervals are,

therefore, primarily determined by medical judgment, taking

possible pacemaker dependency into consideration.

The following notes are meant to stress certain product features,

which are of importance for follow-up visit. For detailed

information on follow-up procedures and medical aspects,

please refer to the pertinent medical literature.

A detailed description of the follow-up functions and the

programming procedures are provided in the corresponding

software manual.

CAUTION

Programming Modifications

changes should only be made after careful clinical

assessment. Clinical judgment should be used when

–

Extreme programming

programming permanent pacing rates below 40 ppm or above

100 ppm.

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4. Real-Time IEGM

Stratos CRT-Ps offer the option of real-time transmission of the

unfiltered intracardiac electrogram (IEGM). In the

Stratos devices, it is possible to simultaneously transmit the

IEGM from all three channels as well as the IEGM marker

channel.

The IEGM simultaneously recorded in the four

channels at a scan rate of 256 Hz. All the markers from the

three channels are also transmitted together with the IEGM. The

IEGM and markers together with the surface ECG can be

displayed directly on the screen of the programmer, on a

connected ECG recorded or they can be printed by the

programmer printer.

NOTE:

When interpreting IEGM, any limitations that result from

applying the programmer head (which contains the magnet)

must always be considered.

4.1

IEGM Recordings

The recording of the intracardiac information over a short

period of time before the tachycardic phase provides

valuable details about the arrhthmogenesis of the

tachycardia. An IEGM recoding can be triggered by the

following events:

•

High atrial rates (AF recording)

Mode switching recording

High ventricular rate recording

Patient-triggered recording

Every instantaneous recording provides information from

the recording period about:

•

The type of triggering event

Time and date of the recording

Sensed and paced events in the atrium and the ventricle

including the IEGM, markers and events during the

refractory period an in the PMT protection window.

•

Duration of the triggering events

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A total of 64 recordings can be stored. Each of the four

triggering types of recording can be assigned a specific number

(i.e., X out of 64). When a newly saved recording exceeds the

programmed number of recordings per event, the oldest

recording is deleted. An exception is the first recording and

those with the longest duration for each event. These are not

over-written.

NOTE:

The total length of each recording can be up to 10 seconds.

While the associated marker chain is always 10 seconds

long, the associated IEGM can be shorter depending on the

amplitude and rate since the rate and amplitude influence

the amount of data to be saved.

In Snap-Shot Pretrigger, it is possible to define the percentage of

the recordings before the trigger event.

In addition, it is possible to make a recording at the end of the

tachycardia (criterion for deactivation) of the respective event

(exception: patient-triggered recordings that do not last).

At the next follow-up examination, the programmer automatically

notes the recordings that have been made. When interrogated,

the recording appears on the screen.

Note: If the recording has been triggered by the patient (by

placing a magnet over the pacemaker), make sure that the

synchronous magnet effect is selected.

CAUTION

IEGM – Due to the compression processes that the signals

undergo, the IEGM recordings are not suitable for making

some specific cardiac diagnoses, such as ischemia; although,

these tracings may be useful in diagnosing arrhythmias,

device behavior or programming issues.

If the “patient-triggered recording function has been activated,

please instruct the patient on how to use the magnet to trigger

an IEGM recording.

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Stratos LV/LV-T Technical Manual 123

5. Battery, Pulse and Lead

Data

The following pulse, battery and lead data can be measured

noninvasively by means of analog telemetry:

Table 25. Measurable Parameters of Analog Telemetry

Parameters

Battery voltage

Battery impedance

Battery current

Pulse voltage

Pulse current

Pulse energy

Pulse charge

Lead impedance

Measuring Unit

kΩ

µA

µJ

µC

Ω

5.1

Threshold Test - Testing the Pacing

Function

Stratos CRT-Ps are equipped with a high-precision threshold

test with a resolution of 0.1 V ranging from 0.1 V to 7.2 V. The

threshold test is activated as a temporary program whose

specific operation is defined by the applicable software version.

The threshold is determined by observing the ECG. Likewise, all

determinations of threshold or threshold margin, by any means,

should only be performed by use of temporary programming to

permit immediate reactivation of the permanent program in case

of loss of capture.

Removal of the programmer head

immediately stops the test and reactivates the permanent

program. Please refer to the appropriate software technical

manual for a description of the threshold test operation.

The threshold test should be performed with the pulse width

programmed to the same value as that selected for the

permanent program. To ensure pacing, the pacing rate of the

threshold test program should exceed the patient's intrinsic rate.

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124 Stratos LV/LV-T Technical Manual

To determine the threshold, the ECG must be observed

continuously. Based on the measured threshold, the pulse

amplitude for the permanent program should be adjusted.

Please consult the pertinent medical literature for specific

recommendations regarding necessary safety margins.

NOTE:

With successful biventricular pacing of patients with

congestive heart failure, the QRS complex should be visibly

shortened.

5.2

P/R Measurement - Testing the

Sensing Function

Stratos CRT-Ps provide a P-/R-wave test for measuring the

amplitude of intrinsic events during follow-up examination. The

test determines the minimum, mean and maximum amplitude

values over a programmable period of time. In addition, these

values may be printed out.

To permit evaluation of the sensing function, the pacing rate

must be lower than the patient's intrinsic rate. In demand

pacing, the proper sensing function can be recognized if the

interval between intrinsic events and the following pacing pulse

equals the basic interval (if no Hysteresis is programmed).

For evaluation of the sensing function, the CRT-P features an

intracardiac electrogram (IEGM) with marker signals to indicate

sensed and paced events. In addition, triggered pacing modes

can be selected which, synchronously to the detection of an

intrinsic event, emit a pacing pulse and mark the sensed event

and its timing on the ECG.

Especially with unipolar sensing functions, the selected

sensitivity level should be checked for possible interference from

skeletal myopotentials.

If oversensing is observed, the

programming of a lower sensitivity (higher value), or bipolar

sensing function, if the implanted lead is bipolar, should be

evaluated.

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5.3

Testing for Retrograde Conduction

Retrograde conduction from the ventricle to the atrium can be

assumed when a 1:1 relationship between the ventricular

stimulation and atrial depolarization has been obtained with a

constant coupling interval during ventricular stimulation. The

Stratos CRT-Ps feature

test for measuring retrograde

conduction time. During operation of this test, the patient is

paced at an increased ventricular rate over several cycles while

the retrograde conduction time is measured.

Both the programmer display and printout provide measured

retrograde conduction times (minimum, mean and maximum).

The duration of time that the test is conducted may be selected.

To prevent retrograde P-waves from triggering ventricular

pulses, thereby mediating a “re-entry” tachycardia (pacemaker

mediated tachycardia, PMT), the programmed post-ventricular

atrial refractory period must be longer than the retrograde

conduction time.

5.4

Non-Invasive Programmed

Stimulation (NIPS)

WARNING

NIPS - Life threatening ventricular arrhythmias can be

induced by stimulation in the ventricle. Ensure that an

external cardiac defibrillator is accessible during tachycardia

testing.

Only physicians trained and experienced in

tachycardia induction and reversion protocols should use non-

invasive programmed stimulation (NIPS).

5.4.1 Description

The implanted CRT-P/lead system may be used in conjunction

with the programmer to generate externally controlled pacing

pulses. Burst Stimulation or Programmed Stimulation may be

selected with up to four extra stimuli at pacing rates to 800 ppm.

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126 Stratos LV/LV-T Technical Manual

5.4.2 Burst Stimulation

Burst Stimulation offers a burst of pacing pulses to either atrium

or ventricle when the programming wand is placed directly over

the CRT-P. The duration of the burst is as long as the burst key

on the programmer is touched. When the burst key is no longer

touched, the program reverts to the backup program. Should the

wand be removed, the pulse generator reverts to the permanent

program.

Burst Stimulation may be stepped up or down from the nominal

value to user-defined high or low limits as long as the selection is

touched on the touch screen. When the Step Up or Step Down

key is touched, NIPS is invoked starting at the nominal burst rate

and then steps up or down respectively in 25 ppm steps. As

soon as the step up or step down key is released, NIPS

terminates.

Subsequent inductions resume at the initially

programmed burst rate.

5.4.3 Programmed Stimulation

Programmed Stimulation offers burst pacing at specifically

defined intervals that are user defined. Programmed stimulation

offers S1-S1, S1-S2, S2-S3, S3-S4, S4-S5 individual intervals.

In addition, up to 7 cycles are available containing

programmable pause of up to 50 seconds. The last selected

interval decrements in 0 to 100 ms steps. As with Burst

Stimulation, the pacing mode switches to the permanent

program when the wand is removed.

5.4.4 Back up Pacing

The back up pacing program remains active once NIPS has

been selected and remains active during burst or programmed

burst stimulation and within this menu. This program remains

active until the Stop touch key is pressed.

CAUTION

Short Pacing Intervals – Use of short pacing intervals (high

pacing rates) with long atrial and/or ventricular refractory

periods may result in intermittent asynchronous pacing and,

therefore, may be contraindicated in some patients.

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5.4.5 NIPS Safety Features

The BIOTRONIK offers the following safety features during NIPS

sessions.

•

Before the NIPS feature can be used, NIPS must be

specifically selected and then is released through user

acknowledgment. In addition, before NIPS is performed

in the Ventricle, the user must acknowledge that

delivering NIPS into the Ventricle may induce dangerous

arrhythmias.

•

When the battery voltage has reached the Elective

Replacement Indicator point (ERI), the NIPS feature is

no longer available.

Ventricular pacing support is available to CRT-P

dependent patients during burst or programmed burst

stimulation through the back up pacing program as long

as the wand is within 15 cm of the CRT-P. Removing

the programmer wand or placement to distance greater

than 15 cm from the implanted device returns the CRT-P

to its permanent program.

•

NIPS may only be programmed temporarily.

NOTE:

High pacing rates and pulse amplitudes together with wide

pulse widths may temporarily decrease the amplitude of the

pacing pulse. The pacing pulse must be continuously

verified with an ECG to assure effectiveness.

To perform NIPS function, the programmer wand must be

placed directly over the CRT-P to enable continuous

telemetry.

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6. Other Functions/Features

Stratos CRT-Ps offer many additional functions and features to

assist with the physician in the care of the pacemaker patient.

6.1

Temporary Programming

CAUTION

OFF Mode – The OFF mode can be transmitted as a

temporary program only to permit evaluation of the patient’s

spontaneous rhythm. (see Section 2.1.11).

A temporary program is a pacing program which remains

activated while the programming head is positioned over the

CRT-P. Upon removal of the programming head (at least 10 cm

away from the CRT-P), the temporary program will be

automatically deactivated and the permanent program will again

be in effect.

Generally, every pacing program displayed on the programmer

screen may be transmitted as a temporary program by pressing

the key designated on the programmer keyboard. With few

exceptions, this also applies to pacing programs containing a

parameter conflict, which cannot be programmed as permanent

programs. Temporary programming facilitates follow-up and

enhances patient safety. Test programs affecting patient safety,

like pacing threshold measurements in a pacemaker-dependent

patient, should be activated as a temporary program only.

When interrogating Stratos CRT-Ps, the permanent program will

always be displayed and documented, even though a temporary

program was activated during the interrogation.

During temporary program activation, the rate adaptation, trend

monitor, and the event counter are always inactive.

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130 Stratos LV/LV-T Technical Manual

6.2

Patient Data Memory

Individual patient data can be stored in the Stratos CRT-Ps.

For example, the following are stored:

•

Patient name

Patient index (how the patient name is coded)

Implantation date

Symptoms

Etiology

ECG indication

QRS width

LV ejection fraction

Lead polarity

6.3

Safe Program Settings

Activating the preset values for the Safe Program is a quick and

convenient way to provide VVI / SSI pacing at a high output

setting in urgent situations. Listed in Table 26 are the Safe

Program settings for Stratos CRT-Ps.

Table 26: Safe Program Settings

Parameter

Safe Program Settings

VVI

Mode

Pacing Rate

70 ppm

Amplitude

Pulse Width

4.8 V (ventricle)

1.0 ms

Sensitivity

2.5 mV

Ventricular Refractory Period

Pacing Polarity

Sensing Polarity

Single Chamber Hysteresis

Magnet Effect

300 ms

Unipolar

OFF

AUTO

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6.4

Magnet Effect

Automatic Magnet Effect:

After magnet application the pulse generator paces at 90 ppm

for 10 cycles asynchronously. Thereafter, the pulse generator

paces synchronously at the programmed basic rate. During

asynchronous pacing, the AV interval is reduced to 100 ms.

Asynchronous Magnet Effect:

When programmed to asynchronous operation, magnet

application results in asynchronous pacing. Stratos CRT-Ps

pace asynchronously at 90 ppm as long as the magnet is over

the CRT-P. Upon magnet removal, the current basic interval is

completed before the CRT-P reverts to its original operating

mode.

If the magnet effect is set to asynchronous, the AV delay is

reduced to 100 ms (or the programmed AV delay, whichever is

shorter).

Shortening of the AV delay to 100 ms during

asynchronous AV sequential stimulation is provided to avoid

ventricular fusion beats in the presence of intact AV conduction.

This allows efficient diagnosis of ventricular capture or failure to

capture.

Synchronous Magnet Effect:

If the magnet effect is programmed to synchronous operation,

magnet application does not affect timing and sensing behavior

of the CRT-P. Synchronous operation is of particular importance

during follow-up, if sensing and inhibition functions are desired

during magnet application.

Trend monitor and event counter operation is interrupted during

magnet application with either ‘Asynchronous’ or ‘Synchronous’

magnet effect.

6.5

Position Indicator

The position indicator facilitates positioning of the programmer

head. The programmer optically and acoustically indicates

whether the programmer head is in communication with the

CRT-P.

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132 Stratos LV/LV-T Technical Manual

6.6

Pacing When Exposed to

Interference

CAUTION

EMI – Computerized systems are subject to (Electromagnetic

Interference (EMI) or “noise”. In the presence of such

interference, telemetry communication may be interrupted and

prevent programming of the Stratos CRT-P.

A sensed event occurring during the interference interval will

continuously reset that interval for the corresponding chamber

without resetting the basic interval. Depending upon whether the

interference (electromagnetic interference, muscle potentials,

etc.) is detected by the atrial and/or ventricular channel, atrial

and/or ventricular asynchronous pacing at the programmed

timing intervals will result for the duration of the interference.

The interference interval has a duration of 125 ms. If the

detected rate exceeds 480/min (8 Hz), then the interference

interval remains refractory during the entire basic interval.

Depending on the programmed pacing mode and the channel in

which electromagnetic interference (EMI) occurs, Table 27

details the resulting pacing modes for the duration of exposure to

EMI.

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Table 27: Response to EMI

EMI* (A) EMI* (V)

DVD(R) DAD(R)

MODE

DDD(R)

EMI* (A+V)

DOO(R)

---

VOO(R)

---

DDI(R)

DVI(R)

VDD(R)

VVI(R)

AAI(R)

DDT

DDI/T

DVT

VDT

DVI(R)

---

VVI(R)

---

AOO(R)

DVT

---

VVT

---

DAI(R)

DOO(R)

VAT(R)

VOO(R)

---

DAT

DOO

---

VOO

---

DOO

VAT

VOO

---

VDI

VVT

AAT

AOO

---

* EMI = Electromagnetic Interference

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7. Product Storage and

Handling

7.1

Sterilization and Storage

Stratos CRT-Ps are shipped in a cardboard box, equipped with a

quality control seal and product information label. The label

contains the model specifications, technical data, serial number,

expiration date, and sterilization and storage information for the

particular CRT-P. The box contains a double blister container

with the CRT-P and product documentation.

The Stratos CRT-P and its accessories have been sealed in a

container and gas sterilized with ethylene oxide. To assure

sterility, the container should be checked for integrity prior to

opening. If a breach of sterility is suspected, return the CRT-P to

BIOTRONIK.

CAUTION

Storage (temperature) – Recommended storage temperature

range is 5° to 55°C (41°-131°F). Exposure to temperatures

outside this range may result in CRT-P malfunction (see

Section 7.1).

Low Temperatures – Exposure to low temperatures (below

0°C) may cause a false elective replacement indication to be

present. If this occurs, warm the device to room temperature

and reset the ERI with magnet application (see Section 7.1).

Handling – Do not drop. If an unpackaged CRT-P is

dropped onto a hard surface, return it to BIOTRONIK (see

Section 7.1).

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CAUTION

FOR SINGLE USE ONLY - Do not re-sterilize the CRT-P or

accessories packaged with the CRT-P, they are intended for

one-time use.

Device Packaging – Do not use the device if the packaging is

wet, punctured, opened or damaged because the integrity of

the sterile packaging may be compromised. Return the

device to BIOTRONIK.

Storage (magnets) – Store the device in a clean area, away

from magnets, kits containing magnets, and sources of

electromagnetic interference (EMI) to avoid damage to the

device.

Use Before Date – Do not implant the device after the USE

BEFORE DATE because the device may have reduced

longevity.

If a replacement CRT-P is needed, contact your local

BIOTRONIK representative.

7.2

Opening the Sterile Container

Stratos CRT-Ps are packaged in two plastic containers, one

within the other. Each is individually sealed and then sterilized

with ethylene oxide. Due to the double packing, the outside of

the inner container is sterile and can be removed using standard

aseptic technique and placed on the sterile field.

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Peel off the sealing paper of

the

outer

container

indicated by the arrow.

Take out the inner sterile

container by the gripping tab

and open it by peeling the

sealing paper as indicated by

the arrow.

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CAUTION

Muscle or Nerve Stimulation – Inappropriate muscle or

nerve stimulation may occur with unipolar pacing when using

a non-coated Stratos CRT-P.

Myopotential Sensing

–

The filter characteristics of

BIOTRONIK implantable devices have been optimized to

sense electrical potentials generated by cardiac activity and to

reduce the possibility of sensing skeletal myopotentials.

However, the risk of pulse generator operation being affected

by myopotentials cannot be eliminated, particularly in unipolar

systems.

Myopotentials may resemble cardiac activity,

resulting in inhibition of pacing, triggering and/or emission of

asynchronous pacing pulses, depending on the pacing mode

and the interference pattern. Certain follow-up procedures,

such as monitoring pulse generator performance while the

patient is doing exercises involving the use of pectoral

muscles, as well as Holter monitoring, have been

recommended to check for interference caused by

myopotentials. If sensing of myopotentials is encountered,

corrective actions may include selection of a different pacing

mode or sensitivity setting.

7.3

Pulse Generator Orientation

The Stratos CRT-Ps may be used in either the left or right side

pectoral implants. Either side of the CRT-Ps can face the skin to

facilitate excess lead wrap.

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Stratos LV/LV-T Technical Manual 139

8. Lead Connection

8.1

Lead Configuration

The Stratos CRT-Ps allows programming of separate lead

polarities for pacing and sensing. Lead polarity can also be

programmed separately in both the atrial and ventricular

channels.

CAUTION

Lead Configuration – The polarity of the implanted lead

dictates what lead configuration can be programmed for the

CRT-P. Pacing will not occur with a unipolar lead if the lead

configuration of the respective channel is programmed to

bipolar (see Section 8).

Atrial Channel

In a unipolar lead configuration, the CRT-P pace and sense

between the tip electrode of the atrial lead (cathode) and the

housing (anode). In a bipolar lead configuration, the CRT-Ps

pace and sense between the tip and ring electrodes of the atrial

lead.

Therefore, bipolar lead polarity should only be

programmed when a bipolar atrial lead is implanted.

Ventricular Channel

The Stratos CRT-Ps have a specially designed header that

allows sensing with only the RV channel while pacing in both the

right and left ventricles.

Biventricular Therapy requires

programming of a bipolar or unipolar pacing configuration in the

ventricle as desired. Table 28 summarizes the sensing and

pacing configuration in the ventricle.

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140 Stratos LV/LV-T Technical Manual

Table 28: Lead Configuration

Configuration

Description

RV tip Æ RV ring

RV tip Æ Case

RV tip Æ RV ring

RV tip Æ Case

LV tip Æ LV ring

LV tip Æ Case

Sensing^*

bipolar

unipolar

bipolar

unipolar

bipolar

Pacing^†

unipolar

8.2

Lead Connection

Stratos CRT-Ps have been designed and are recommended for

use with bipolar or unipolar leads having an IS-1 connector.

CAUTION

Unipolar/Bipolar – If the pacing or sensing function is to be

programmed to bipolar in the atrial channel, it must be

verified that bipolar leads have been implanted in that

chamber. If the atrial lead is unipolar, unipolar sensing and

pacing functions must be programmed in that chamber.

Failure to program the appropriate lead configuration could

result in patient experiencing entrance and/or exit block.

In addition, if the atrial lead polarity setting within the Patient

Data Memory has been set to bipolar, the polarity of the

corresponding implanted lead must be confirmed to be

bipolar.

Overview of the Lead Polarities

If a bipolar lead is connected to the CRT-P, unipolar or bipolar

configurations can be programmed for pacing and sensing. As

compared to bipolar pacing, the unipolar pacing pulse has the

advantage of being clearly identifiable on the ECG. Unipolar

pacing occasionally results in muscle stimulation in the device

pocket or diaphragm.

^*RV only

^†RV only and BiV, BiV = RV + LV with programmed VV-Delay

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Stratos LV/LV-T Technical Manual 141

Lead Compatibility

The Stratos CRT-Ps have been designed for connection with a

bipolar lead in the atrium and two bipolar leads in the ventricle.

All connections are IS-1 compatible. Appropriate adapters (e.g.,

A1-A) should be fitted when using leads with a different

connection.

NOTE:

Connecting systems with a 3.2 mm configuration that do not

expressly claim to agree with the IS-1 dimensions generally

have to be regarded as incompatible with IS-1 connectors

and can only be used with BIOTRONIK products together

with an appropriate adapter. For questions regarding lead-

device

compatibility,

consult

your

BIOTRONIK

representative.

In case of device replacement, ensure that the existing lead

connector and leads are not damaged.

CAUTION

Lead / CRT-P Compatibility – Because of the numerous

available 3.2-mm configurations (e.g., the IS-1 and VS-1

standards), lead/ CRT-P compatibility should be confirmed

with the CRT-P and/or lead manufacturer prior to the

implantation of the system.

IS-1, wherever stated in this manual, refers to the international

standard, whereby leads and generators from different

manufacturers are assured a basic fit. [Reference ISO 5841-

3:1992(E)].

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142 Stratos LV/LV-T Technical Manual

Connecting the Stratos LV with the IS-1 Connector

In order to avoid programming errors with the Stratos LV, always

connect the leads to the following ports:

Bipolar lead in right atrium

Bipolar lead in right ventricle

Unipolar and/or Bipolar lead in left

ventricle

Figure 10. Connecting the Leads

Stratos CRT-Ps have a self-sealing header. Refer to the

following steps when connecting a lead(s) to the CRT-P.

First, confirm that the setscrew(s) is not protruding into the

connector receptacle. To retract a setscrew, insert the enclosed

torque wrench through the perforation in the self-sealing plug at

an angle perpendicular to the lead connector until it is firmly

placed in the setscrew.

CAUTION

Setscrew Adjustment – Back-off the setscrew(s) prior to

insertion of lead connector(s) as failure to do so may result in

damage to the lead(s), and/or difficulty connecting lead(s).

Cross Threading Setscrew(s)

–

To prevent cross

threading the setscrew(s), do not back the setscrew(s)

completely out of the threaded hole. Leave the torque wrench

in the slot of the setscrew(s) while the lead is inserted.

Rotate the wrench counterclockwise until the receptacle is clear

of obstruction. Then connect the pacing leads as described

below.

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Stratos LV/LV-T Technical Manual 143

1. Insert the enclosed torque wrench

through the perforation in the self-

sealing plug at an angle perpendicular

to the lead connector until it is firmly

placed in the setscrew.

2. Insert the lead connector pin into the

connector receptacle of the CRT-P

without bending the lead until the

connector pin becomes visible behind

the setscrew. Hold the connector in

this position.

3. Securely tighten the setscrew of the

connector clockwise with the torque

wrench until torque transmission is

limited by the wrench.

4. After retracting the torque wrench, the

perforation will self-seal. The proximal

electrode

bipolar

leads

automatically connected. Connect the

second lead as described above.

5. Attach the other ventricular lead to the

right ventricular port (RV) and the atrial

lead to the right atrial port (RA) in the

same manner.

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144 Stratos LV/LV-T Technical Manual

6. Pass non-absorbable ligature through

the hole in the connector receptacle to

secure the CRT-P in the pocket.

CAUTION

Tightening Setscrew(s)

–

Do not overtighten the

setscrew(s). Use only the BIOTRONIK supplied torque

wrench.

Sealing System – Be sure to properly insert the torque

wrench into the perforation at an angle perpendicular to the

connector receptacle. Failure to do so may result in damage

to the plug and its self-sealing properties.

NOTE:

Do not lubricate the grommets.

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Stratos LV/LV-T Technical Manual 145

9. Elective Replacement

Indication (ERI)

Service times for the Stratos CRT-Ps vary based on several

factors, including battery properties, storage time, lead system

impedance, programmed parameters, amount of pacing and

sensing required, and circuit operating characteristics. Service

time is the time from beginning of service (BOS) to the end of

service (EOS). To assist the physician in determining the

optimum time for pulse generator replacement, an elective

replacement indicator is provided that is activated when the

battery cell capacity drops to a predetermined level. The

following table defines the different service cycles (at standard

settings, 37°C, and with a lead impedance of 500 ohms). The

beginning of the replacement cycle is displayed on the

programmer after pulse generator interrogation and appears on

the printout.

Table 29: Service Cycle Definitions

Abbreviation

Service

Cycle

Definition

BOS

Beginning of Normal service cycle;

Service

battery in good condition

ERI

Elective

Identifies the time of

Replacement elective replacement

Indication

indication. The rate

occurring at ERI depends

upon the programmed

mode and magnet

application.

EOS

End of

Service

Identifies the end of the

elective replacement

indication period.

The Stratos CRT-Ps indicate the need for replacement by a

defined decrease in the programmed pacing rate without a

magnet applied.

The rate change is dependent on the

programmed pacing mode.

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146 Stratos LV/LV-T Technical Manual

The pacing rate decreases by 11% when programmed to

DDD(R), DDT(R), D00(R), VDD(R), VDI(R), VDT(R), VVI(R),

VVT(R), AAI(R), AAT(R), or A00(R).

In DDI(R), DDI/T(R), DVI(R), and DVT(R) modes, only the V-A

delay is extended by 11%. This reduces the pacing rate by

4.5-11%, depending on the programmed AV delay.

The Stratos CRT-Ps indicate the need for replacement by a

defined decrease of its rate after magnet application and the

programmer displays it upon interrogation of the programmed

parameters. The magnet rate in all modes decreases as shown

in Table 30.

Table 30: Stratos CRT-Ps behavior after reaching ERI

Magnet Mode

Cycles 1-10 after

After Cycle 10

magnet application

Automatic

Asynchronous, basic

rate at 80 ppm

Synchronized with

basic rate reduced

by 4.5 - 11%

Asynchronous Asynchronous, basic

rate at 80 ppm

Asynchronous with

basic rate at 80

Synchronous

Synchronized with

basic rate reduced

by 4.5 - 11%

Synchronized with

basic rate reduced

by 4.5 - 11%

If the CRT-P is programmed to dual chamber pacing, it will

switch to single chamber pacing when it reaches the elective

replacement indication. The “ERI mode” varies according to the

programmed pacing mode and is indicated by the pulse

generator. Upon reaching the replacement indication, the

following functions are automatically deactivated:

•

Post-AES pacing

Preventive overdrive pacing

Rate adaptation

Rate fading

Statistics

Snap-shots (Holter)

Automatic lead check

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Stratos LV/LV-T Technical Manual 147

The following functions remain active when the replacement

indication is reached:

•

Mode switching

PMT detection and termination

Biventricular synchronization

NOTE:

The statistics are frozen when ERI is reached.

WARNING

High Output Settings – High output settings combined with

extremely low lead impedance may reduce the life expectancy

of the Stratos CRT-Ps. Programming of pulse amplitudes,

higher than 4.8 V, in combination with long pulse widths

and/or high pacing rates may lead to premature activation of

the replacement indicator.

Table 31 shows the expected longevity (in months) from BOS to

ERI at standard program for Stratos CRT-Ps.

The

Stratos programmer software provides an estimated time to ERI

in months and years that is updated each time the device is

reprogrammed.

understand the longevity effects of modifying programmed

parameters. The data is based on the referenced lead

This estimation allows the physician to

impedance for each chamber, 100% biventricular pacing and the

data supplied by the battery manufacturer.

Table 31: Nominal pulse generator longevity

Standard^*

Pulse Generator

(BOS - ERI) in Months

Stratos LV / LV-T (500 ohms)

Stratos LV / LV-T (1000 ohms)

^*Standard: 60 ppm, 3.6 V, 0.4 ms

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148 Stratos LV/LV-T Technical Manual

Table 32 shows the mean^*expected time intervals (in months)

from ERI to EOS at standard program for Stratos CRT-Ps. All

service intervals, including the above-cited nominal longevity,

are based on the battery discharge behavior and the hybrid

circuit properties including current consumption and replacement

indicator. The statistical calculations are based on 500 ohm lead

impedances, 100% pacing, and data supplied by the battery

manufacturer.

Table 32: Remaining Expected Service time (ERI to EOS)

Pacing Program

Standard^†, Mean

Program with high pulse energy^‡

Stratos LV, (months)

^*50% of all pacemakers reach or exceed the given value

^†Standard: DDDR, 60 ppm, 3.6 V, 0.4 ms

^‡High: DDDR, 90 ppm, 4.8 V, 1.0 ms

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Stratos LV/LV-T Technical Manual 149

10. Explantation

Explanted devices and accessories may not be reused.

Explanted CRT-Ps can be delivered to the local BIOTRONIK

representative or the BIOTRONIK home office for expert

disposal. If possible, the explanted devices should be cleaned

with a sodium-hyperchlorine solution of at least 1% chlorine and,

thereafter, washed with water prior to shipping.

All implantable electronic devices should be explanted before

cremation of a deceased patient.

CAUTION

Device Incineration - Never incinerate a CRT-P. Be sure the

CRT-P is explanted before a patient who has died is

cremated. (see Section 10)

Explanted Devices – Return all explanted devices to

BIOTRONIK.

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150 Stratos LV/LV-T Technical Manual

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Stratos LV/LV-T Technical Manual 151

11. Technical Data

11.1 Available Pacing Modes

DDDR, DDTRA, DDTR, DDIR, DDITR, DVIR, DVTR, DOOR,

VDDR, VDTR, VDIR, VVIR, VVTR, VOOR, AAIR, AATR, AOOR

DDD DDTA, DDT, DDI, DDIT, DVI, DVT, DOO, VDD, VDT, VDI,

VVI, VVT, VOO, AAI, AAT, AOO, OFF

VV synchronization for the Stratos CRT-Ps: BiV RV RV-T, OFF

11.2 Pulse- and Control Parameters

Basic Rate

32... (1)...60... (1)...88... (2)...122... (3)...140... (5)...180 ppm

Night Rate

Off, 32... (1)...88... (2)...122... (3)...140... (5)...180 ppm

Night Rate Start Time

00:00... (00:10)...23:50

Rate Hysteresis

Off; -5... (5)...-90 bpm

Repetitive Rate Hysteresis

Off; 1… (1)…15

Scan Rate Hysteresis

Off: 1… (1)…15

Upper Rate

90… (10)…180 ppm

UTR Response

2:1; Wenckebach (WKB)

Upper Tracking Rate, Atrium

Off, 200 ppm

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152 Stratos LV/LV-T Technical Manual

Dynamic AV Delay (Dual chamber only)

low; medium; high; individual; fixed

AV Delay Values (Dual chamber modes only)

15… (5)…300

AV Hysteresis

Off; 10… (10)…100 ms

Repetitive AV Hysteresis

Off; 1… (1)…10

Scan AV Hysteresis

Off; 1… (1)…10

Sense Compensation

Off; -10… (-10)…-120 ms

Safety AV Delay

100 ms

Ventricular Blanking Time

30… (5)…70 ms

Magnet effect

Automatic; Auto; asynchronous; synchronous

Asynchronous Magnet Effect: paces at 90 ppm.

Automatic Magnet Effect: 10 cycles at 90 ppm asynchronous;

thereafter synchronous with the programmed basic rate

Synchronous Magnet Effect: synchronous with programmed

basic rate

High Rate Protection

205…215 ppm

Pulse Amplitude

0.2... (0.1)...3.6... (0.1)...6.2; 7.2 V

(3 channels separately programmable)

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Stratos LV/LV-T Technical Manual 153

Pulse Width

0.1; 0.2; 0.3; 0.4; 0.5…(0.25)…1.5 ms

(3 channels separately programmable)

Sensitivity

0.1... (0.1)...1.0… (0.1)…1.5… (0.5)...7.5 mV

0.5... (0.5)...2.5... (0.5)...7.5 mV

First Chamber Paced

VV Delay after Pace/Sense

5 ms

Ventricular Refractory Period

150… (25)…500 ms

Atrial Refractory Period

Auto; 225… (25)…775 ms

Atrial Far-field Protection

After Vp: 30… (10)…220 ms

After Vs: 30… (10)…200 ms

PMT Detection/Termination

Off; On

PMT VA Criterion

250… (10)…500

PMT Protection

Auto; 175… (25)…600 ms

PMT Protection after VES

400… (25)…600 ms

Mode Switching

Off; On

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154 Stratos LV/LV-T Technical Manual

Intervention Rate

100… (10)…250 ppm

X-out-of-8 Activation Criterion

3… (1)…8

Z-out-of-8 Termination Criterion

3… (1)…8

DDI(R) Basic Rate

32… (1)…88… (2)…122… (3)…140… (5)…180 ppm

Overdrive Modes:

Off; On

Available in the modes DDD, DDTA, AAI, AAT with and without

rate adaptation

Maximum Overdrive Pacing Rate

90… (5)…160 ppm

Overdrive Pacing Increment (Rate Increase)

2… (2)…10 ppm

Overpacing Level (Rate Drop After)

1… (1) …32 cycles

Post-AES Pacing

Off; On

AES Increment

5… (5)…40 ppm

AES Prematurity

5…50%

VES discrimination after As

OFF; 250… (50)…450 ms

Rate Fading

Off; On

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Stratos LV/LV-T Technical Manual 155

Rate Fading Rate Increase

0.5; 1; 2… (1)…6 ppm/cycle

Rate Fading Rate Decrease

0.25; 0.5… (0.25)…1.25 ppm/cycle

Lead Configuration

Pacing for the Stratos LV / LV-T:

UNIP; BIPL (3 separate channels)

Sensing for the Stratos LV / LV-T:

UNIP; BIPL (2 separate channels; 3 IEGM channels)

Lead check

Off; On (3 separate channels)

Rate Adaptation

Off; On

Sensor

Accelerometer

Sensor Gain

Auto; 1…40 (in 32 steps)

Automatic Sensor Gain

Off; On

Sensor Threshold

Very low; low; medium, high; very high

Rate Increase

0.5; 1… (1)…6 ppm/cycle

Rate Decrease

0.25… (0.25)…1.25 ppm/cycle

Maximum Sensor Rate

90… (5)…120… (5)…180 ppm

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156 Stratos LV/LV-T Technical Manual

11.3 Diagnostic Memory Functions

IEGM Recoding AF

OFF; 3… (1)…31 count

AF Detection Rate

100… (10)…300… (20)…400 ppm

AF End Rate

100… (10)…300… (20)…400 ppm

Mode Switching Recording

Off; 3… (1)…31 count

High Ventricular Rate Recording

OFF; 3… (1)…31 count

Ventricular Sense Rate

100… (10)…250 ppm

Patient Activated Recording

OFF; 1… (1)…31 count

Pre-trigger Recording

0… (10)…80%

Recording when Switching off

Off; On

11.4 Home Monitoring (Stratos LV-T)

Mean Ventricular Heart Rate at Rest – Start Time

00:00... (00:10)...23:50

Event Messages

ON, OFF

Home Monitoring

ON, OFF

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Stratos LV/LV-T Technical Manual 157

Patient-Triggered Messages

ON, OFF

Time of Trend Message

00:00... (00:10)...23:50

11.5 Additional Functions

NOTE:

Availability of the following functions is dependent upon

pulse generator configuration.

•

Permanent IEGM transmission with comprehensive

marker annotation

•

Storing of comprehensive patient data

Comprehensive statistics with AES and VES

classification, Histogram and event counters and Tachy

episode trend

•

Guided follow-up

Retrograde conduction test

NIPS

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158 Stratos LV/LV-T Technical Manual

NIPS Specifications

Burst Mode

Burst Chamber

Atrium, Ventricle

Burst stimulation

Coupling Interval

/ms

None… 2000

Burst Type

Pushbutton, Ramp

Burst Range / ppm 30…800

Programmed

Stimulation

S1-S1

S1-S2, S2-S3,

S3-S4, S4-S5

Cycles

0…10

Pause / ms

No. of intervals

Decrement ms

Modes

Stop… 50

0…100

VOO,VVI, SOO,

SSI, OSO,

Back-up Pacing

OOO,OVO

Rate / ppm

Amplitude / V

Pulse width / ms

30…180

0.1…8.4

0.1, 0.2, 0.3, 0.4,

0.5, 0.75, 1.0, 1.5

Pace Polarity

Bipolar, Unipolar

11.6 Programmers

ICS 3000 Implant Control System

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Stratos LV/LV-T Technical Manual 159

11.7 Default Programs

Stratos LV / LV-T

Parameter/

Function

Mode

Factory settings/

Standard Program

DDD

Safe Program

VVI

BiV RV RV-T

Synchronization

AV delay

150 ms at 60 ppm

120ms at 130

ppm

First Chamber

Paced

VV delay after

pace

VV delay after

sense

5 ms

Pulse

Amplitude

3.6 V (A); 3.6 V

(RV); 3.6 V (LV)

4.8 V

Sensing A/RV

UNIP

UNIP (RV)

Refractory

Period

Auto (A); 250 ms (V)

A: N/A

V: 300 ms

11.8 Materials in Contact with Human

Tissue

•

Housing: Titanium

Connector receptacle: Epoxy resin

Sealing Plugs: Silicone Rubber

11.9 Electrical Data/Battery

NOTE:

At 37º C, with pacing impedance of 500 Ohms.

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160 Stratos LV/LV-T Technical Manual

Parameter

Stratos LV

Pace

Unipolar/bipolar

Pulse form

Polarity

Biphasic, asymmetric

Cathodic

> 10kΩ (RV/LV)

Li/I₂

Input impedance

Power source

Battery voltage at BOS

Conducting surface

Conducting Shape

2.8 V

37.4²

Flattened ellipsoidal

11.10 Mechanical Data

Model

Leads

Size

Mass Volume

30.85 14.0

Stratos

IS-1

6.4 x 50.3 x 57

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Stratos LV/LV-T Technical Manual 161

12. Order Information

Pulse Generator Type

Stratos LV

Order Number

338 200

Stratos LV-T

338 202

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Stratos LV/LV-T Technical Manual 163

Appendix A

Known Software Anomalies

Anomaly

Possible Effect on Patient

or Implant Procedure

General Programmer Issues

If a long patient name is entered The last letters of the patient

without blank spaces, it may be name may be missing from

cut off in the printout under the

section 'Patient Data'

the printout. However, the

patient name is not a therapy-

relevant parameter.

Pacemaker detection disturbed If this occurs, the programmer

after interrogation under EMI

conditions

must be re-started, so that the

Stratos cannot be

communicated with for about

1 minute. The follow-up

process is delayed by this

time.

Display test results on

Limited clarity and

programmer screen and printout consistency in the display of

is inconsistent

measurement values from

follow-up testing.

During transfer of follow-up

Missing programing

information from Stratos CRT-Ps information in the exported

to the GE/CARDDAS system, the data may cause user

following data are not displayed: confusion

• the programmed data and

follow-up data of the left

ventricular channel

• lead data of all channels in

Stratos

Interrogation data after Auto

Display/printout of incorrect

Implant Detect (1.5 h after lead diagnostic information may

attach) may show an incorrect, cause user confusion or

superfluous entry: "AF episodes incorrect diagnosis

detected >48h" in the Event List.

AF statistics are always correctly

displayed.

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Distributed by:

BIOTRONIK, Inc.

6024 Jean Road

Lake Oswego, OR 97035-5369

(800) 547-0394 (24-hour)

(503) 635-9936 (FAX)

Manufactured by:

BIOTRONIK GmbH & Co. KG

Woermannkehre 1

12359 Berlin Germany

M4122-A 5/08

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