Cardiac Resynchronization Therapy
Conditions
Brief summary
The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market submission. Additionally, data from this study will be used to support post-market approval requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.
Interventions
DEVICEACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead
The ACUITY X4 leads are intended for chronic left ventricular pacing and sensing. The leads have 3 tip configuration designs (straight tip, short tip spiral, and long tip spiral), which is intended to provide choices for patients with different anatomies. The RELIANCE 4-FRONT leads are designed for right-side heart applications within the ventricle, atrium, and superior vena cava. It is intended for permanent sensing, pacing, and defibrillation when used with a compatible implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). Subjects were allowed to receive both the ACUITY X4 and RELIANCE 4-FRONT lead.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Every subject had access to two study devices and were followed as a single group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects indicated for a CRT-D that fulfill one of the following 5 criteria\[1\]: 1. Subject with left ventricular ejection fraction (LVEF) less than or equal to 35%, sinus rhythm, left bundle branch block (LBBB) with a QRS duration greater than or equal to 150 ms, and a NYHA class II, III or ambulatory IV symptoms on Guideline-Directed Medical Therapy (GDMT)\* 2. Subject with LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT\* 3. Subject with LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration greater than or equal to 150 ms, and NYHA class III/ ambulatory class IV symptoms on GDMT\* 4. Subject with atrial fibrillation and LVEF less than or equal to 35% on GDMT\* if a) the subject requires ventricular pacing or otherwise meets CRT criteria \[listed here\] and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT 5. Subject on GDMT\* who have LVEF less than or equal to 35% and are undergoing new device placement with anticipated requirement for significant (\>40%) ventricular pacing \*GDMT = Guideline-directed medical therapy (formerly known as optimal pharmaceutical therapy (OPT)), represents optimal medical therapy as defined by ACCF/ AHA guideline-recommended therapies (primarily Class I) * Subject is intended to receive the ACUITY X4 LV lead and RELIANCE 4-FRONT RV lead (optional in Study Phase 1) and BSC CRT-D with quadripolar header as their initial (de novo) cardiac implants * Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative \[LAR\] for documentation of informed consent) and participating in all testing associated with this investigation at an approved center and at the intervals defined by this protocol * Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
Subjects who meet any one of the following criteria will be excluded from this clinical study. * Subject has a known or suspected sensitivity to dexamethasone acetate (DXA) * Subject has a mechanical tricuspid heart valve * Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries\* that are not in conflict and do not affect the following: * Schedule of procedures for the Study (i.e. should not cause additional or missed visits); * Study outcome (i.e. involve medications that could affect the heart rate of the subject); * Conduct of the Study per good clinical practice (GCP) / International Organization for Standardization (ISO) 14155:2011/ 21 Code of Federal Regulations (CFR) 812, local regulations * Subject is currently on the active heart transplant list * Subject has a documented life expectancy of less than twelve months * Women of childbearing potential who are or might be pregnant at the time of study enrollment or CRT-D System implant (method of assessment upon physician's discretion) * Subjects currently requiring chronic dialysis \*Sponsors of such studies/registries should be informed and Boston Scientific must be informed by the investigator about the parallel conduct of these projects in the subject and of the project's basic nature. The decision if a desired mandatory governmental registry or observational study/ registry is in conflict with this exclusion criterion is up to the enrolling investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of ACUITY X4 Spiral Leads Free From Complication Through 6 Months | Implant through 6 months | Lead-related complication-free rate of ACUITY X4 Spiral Leads from implant through 6 months post implant. |
| Percentage of ACUITY X4 Straight Leads Free From Complication Through 6 Months | Implant through 6 months | Lead-related complication-free rate of ACUITY X4 Straight Leads from implant through 6 months post implant. |
| Percentage of ACUITY X4 Leads With Acceptable Pacing Capture Thresholds (PCT) | Implant through 3 months | PCT measurements in the programmed configuration were collected at 3 months post-implant. Programmed configuration refers to the pacing configuration that was selected by the physician to provide LV pacing therapy. The percentage of measurements with PCT ≤ 2.5 V were calculated. |
| Percentage of ACUITY X4 Spiral Leads With Acceptable Pacing Capture Thresholds (PCT) Using the Best Proximal Electrode | 3 months | PCT measurements in the in the proximal zone (electrodes 2, 3, 4) were collected at 3 months post-implant. Physician investigators were instructed to use the best proximal electrode (E2, E3 or E4) as the cathode and the RV lead coil or pulse generator as the anode; best was defined as the electrode with the lowest PCT without phrenic nerve stimulation. The percentage of measurements with PCT ≤ 2.5 V were calculated. |
| Percentage of RELIANCE 4-FRONT Leads Free From Complication Through 3 Months | Implant through 3 months | Lead-related complication-free rate of RELIANCE 4-FRONT Leads from implant through 3 months post implant. |
| Percentage of RELIANCE 4-FRONT Leads Free From Complication From 3 Through 24 Months | 3 months through 24 months | Lead-related complication-free rate of RELIANCE 4-FRONT Leads from 3 through 24 months post implant. |
| Mean Pacing Capture Threshold (PCT) of RELIANCE 4-FRONT Leads at 3 Months | Implant through 3 months | PCT measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant. Measurements were performed using 0.5 millisecond pulse width. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pacing Impedance of RELIANCE 4-FRONT Passive Fixation Leads at 3 Months | 3 months | Pacing impedance measurements from RELIANCE 4-FRONT Passive Fixation leads were collected at 3 months post-implant. |
| Mean Sensed Amplitude of ACUITY X4 Spiral Leads at 3 Months | 3 months | Sensed amplitude measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant. |
| Percentage of Successfully Converted Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads | Within 30 days of implant | Ventricular Tachyarrhythmia (VT/VF) Shock Conversion Efficacy, analyzed within 30 days of implant |
| Mean Sensed Amplitude of ACUITY X4 Straight Leads at 3 Months | 3 months | Sensed amplitude measurements from ACUITY X4 Straight leads were collected at 3 months post-implant. |
| Mean Pacing Impedance of ACUITY X4 Spiral Leads at 3 Months | 3 months | Pacing impedance measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant. |
| Mean Pacing Impedance ACUITY X4 Straight Leads at 3 Months | 3 months | Pacing impedance measurements from ACUITY X4 Straight leads were collected at 3 months post-implant. |
| Mean Detection Time of Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads | Within 30 days of implant | The mean detection time, in seconds, of induced VT/VF episodes occurring within 30 days of implant were evaluated. Subjects were required to implanted with RELIANCE 4-FRONT leads to be evaluated. |
| Mean Sensed Amplitude of RELIANCE 4-FRONT Leads at 3 Months | 3 months | Sensed amplitude measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant. |
| Mean Pacing Impedance of RELIANCE 4-FRONT Active Fixation Leads at 3 Months | 3 months | Pacing impedance measurements from RELIANCE 4-FRONT Active Fixation leads were collected at 3 months post-implant. |
Countries
United States
Participant flow
Pre-assignment details
Participants were not randomized to received a specific lead.
Participants by arm
| Arm | Count |
|---|---|
| NAVIGATE X4 Study Participants All subjects that signed the informed consent were included.
Subjects consent to undergo an implant procedure to receive an ACUITY X4 LV lead and/or a RELIANCE 4-FRONT RV lead.
ACUITY X4 quadripolar coronary venous lead: The ACUITY X4 leads are intended for chronic left ventricular pacing and sensing. The leads have 3 tip configuration designs (straight tip, short tip spiral, and long tip spiral), which is intended to provide choices for patients with different anatomies.
RELIANCE 4-FRONT defibrillation lead: The RELIANCE 4-FRONT leads are designed for right-side heart applications within the ventricle, atrium, and superior vena cava. It is intended for permanent sensing, pacing, and defibrillation when used with a compatible ICD or CRT-D. | 2,244 |
| Total | 2,244 |
Baseline characteristics
| Characteristic | NAVIGATE X4 Study Participants |
|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 10.7 |
| Left Ventricular Ejection Fraction (LVEF) | 25.2 % STANDARD_DEVIATION 6.5 |
| New York Heart Association (NYHA) Classification Class I | 5 Participants |
| New York Heart Association (NYHA) Classification Class II | 667 Participants |
| New York Heart Association (NYHA) Classification Class III | 1485 Participants |
| New York Heart Association (NYHA) Classification Class IV | 54 Participants |
| New York Heart Association (NYHA) Classification Non-Heart Failure Subject | 6 Participants |
| New York Heart Association (NYHA) Classification Not available | 27 Participants |
| QRS duration | 153 milliseconds STANDARD_DEVIATION 22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 22 Participants |
| Race (NIH/OMB) Black or African American | 292 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 129 Participants |
| Race (NIH/OMB) White | 1791 Participants |
| Region of Enrollment United States | 2244 participants |
| Sex: Female, Male Female | 777 Participants |
| Sex: Female, Male Male | 1467 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 491 / 2,244 |
| other Total, other adverse events | 1,768 / 2,200 |
| serious Total, serious adverse events | 1,539 / 2,200 |
Outcome results
Primary
Mean Pacing Capture Threshold (PCT) of RELIANCE 4-FRONT Leads at 3 Months
PCT measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant. Measurements were performed using 0.5 millisecond pulse width.
Time frame: Implant through 3 months
Population: Subjects eligible for endpoint analysis included the first 1544 subjects implanted/attempted with RELIANCE 4-FRONT lead. 1432 of these 1544 had PCT measurements at 3 months and were included in the evaluation. Data were pooled with data from subjects from 2 other studies for official endpoint analysis. Only data from NAVIGATE X4 are presented here.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NAVIGATE X4 Study Participants | Mean Pacing Capture Threshold (PCT) of RELIANCE 4-FRONT Leads at 3 Months | 0.56 Volts (V) |
Comparison: Ho: The 3-month mean PCT ≥ 1.5 Volts, Ha: The 3-month mean PCT \< 1.5 Volts
Primary
Percentage of ACUITY X4 Leads With Acceptable Pacing Capture Thresholds (PCT)
PCT measurements in the programmed configuration were collected at 3 months post-implant. Programmed configuration refers to the pacing configuration that was selected by the physician to provide LV pacing therapy. The percentage of measurements with PCT ≤ 2.5 V were calculated.
Time frame: Implant through 3 months
Population: Subjects eligible for endpoint analysis included the first 764 subjects implanted/attempted with ACUITY X4 lead. 685 of these 764 had PCT measurements at 3 months and were included in the evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVIGATE X4 Study Participants | Percentage of ACUITY X4 Leads With Acceptable Pacing Capture Thresholds (PCT) | 94.0 % of leads with acceptable threshold |
Comparison: Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%
Primary
Percentage of ACUITY X4 Spiral Leads Free From Complication Through 6 Months
Lead-related complication-free rate of ACUITY X4 Spiral Leads from implant through 6 months post implant.
Time frame: Implant through 6 months
Population: This endpoint was limited to the first 536 subjects implanted/attempted with ACUITY X4 Spiral leads
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVIGATE X4 Study Participants | Percentage of ACUITY X4 Spiral Leads Free From Complication Through 6 Months | 98.5 % of leads free from complication |
Comparison: Ho: The Implant through 6-month lead-related complication-free rate ≤ 87%, Ha: The Implant through 6-month lead-related complication-free rate \> 87%
Primary
Percentage of ACUITY X4 Spiral Leads With Acceptable Pacing Capture Thresholds (PCT) Using the Best Proximal Electrode
PCT measurements in the in the proximal zone (electrodes 2, 3, 4) were collected at 3 months post-implant. Physician investigators were instructed to use the best proximal electrode (E2, E3 or E4) as the cathode and the RV lead coil or pulse generator as the anode; best was defined as the electrode with the lowest PCT without phrenic nerve stimulation. The percentage of measurements with PCT ≤ 2.5 V were calculated.
Time frame: 3 months
Population: Subjects eligible for endpoint analysis included the first 536 subjects implanted/attempted with ACUITY X4 Spiral lead. 484 of these 536 had PCT measurements at 3 months and were included in the evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVIGATE X4 Study Participants | Percentage of ACUITY X4 Spiral Leads With Acceptable Pacing Capture Thresholds (PCT) Using the Best Proximal Electrode | 91.1 % of leads with acceptable threshold |
Comparison: Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%
Primary
Percentage of ACUITY X4 Straight Leads Free From Complication Through 6 Months
Lead-related complication-free rate of ACUITY X4 Straight Leads from implant through 6 months post implant.
Time frame: Implant through 6 months
Population: This endpoint was limited to the first 228 subjects implanted/attempted with ACUITY X4 Straight leads
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVIGATE X4 Study Participants | Percentage of ACUITY X4 Straight Leads Free From Complication Through 6 Months | 96.5 % of leads free from complication |
Comparison: Ho: The Implant through 6-month lead-related complication-free rate ≤ 85%, Ha: The Implant through 6-month lead-related complication-free rate \> 85%
Primary
Percentage of RELIANCE 4-FRONT Leads Free From Complication From 3 Through 24 Months
Lead-related complication-free rate of RELIANCE 4-FRONT Leads from 3 through 24 months post implant.
Time frame: 3 months through 24 months
Population: The first 1544 subjects implanted/attempted with RELIANCE 4-FRONT leads were eligible for endpoint analysis. Of these 1544, leads still in service at 3 months were evaluated (n = 1486). Data from participants were pooled with data from subjects from 2 other studies for official endpoint analysis. Only data from NAVIGATE X4 are presented here.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVIGATE X4 Study Participants | Percentage of RELIANCE 4-FRONT Leads Free From Complication From 3 Through 24 Months | 99.3 % of leads free from complication |
Comparison: Ho: The 3- through 24-month lead-related complication-free rate ≤ 94%, Ha: The 3- through 24-month lead-related complication-free rate \> 94%
Primary
Percentage of RELIANCE 4-FRONT Leads Free From Complication Through 3 Months
Lead-related complication-free rate of RELIANCE 4-FRONT Leads from implant through 3 months post implant.
Time frame: Implant through 3 months
Population: This endpoint was limited to the first 1544 subjects implanted/attempted with RELIANCE 4-FRONT leads. Data from participants were pooled with data from 334 subjects from 2 other studies for official endpoint analysis. Only data from NAVIGATE X4 are presented here.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVIGATE X4 Study Participants | Percentage of RELIANCE 4-FRONT Leads Free From Complication Through 3 Months | 98.2 % of leads free from complication |
Comparison: Ho: The Implant through 3-month lead-related complication-free rate ≤ 93%, Ha: The Implant through 3-month lead-related complication-free rate \> 93%
Secondary
Mean Detection Time of Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads
The mean detection time, in seconds, of induced VT/VF episodes occurring within 30 days of implant were evaluated. Subjects were required to implanted with RELIANCE 4-FRONT leads to be evaluated.
Time frame: Within 30 days of implant
Population: Subjects eligible for endpoint analysis included the first 1544 subjects implanted/attempted with RELIANCE 4-FRONT lead. 557 of these 1544 had induced VT/VF episodes within 30 days of implant with detection time data and were included in the evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVIGATE X4 Study Participants | Mean Detection Time of Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads | 3.14 seconds |
Comparison: Ho: The mean detection time ≥ 4.5 seconds, Ha: The mean detection time \< 4.5 seconds
Secondary
Mean Pacing Impedance ACUITY X4 Straight Leads at 3 Months
Pacing impedance measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.
Time frame: 3 months
Population: Subjects eligible for endpoint analysis included the first 228 subjects implanted/attempted with ACUITY X4 Straight lead. 202 of these 228 had pacing impedance measurements at 3 months and were included in the evaluation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NAVIGATE X4 Study Participants | Mean Pacing Impedance ACUITY X4 Straight Leads at 3 Months | 805 ohms |
Comparison: Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms
Secondary
Mean Pacing Impedance of ACUITY X4 Spiral Leads at 3 Months
Pacing impedance measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.
Time frame: 3 months
Population: Subjects eligible for endpoint analysis included the first 536 subjects implanted/attempted with ACUITY X4 Spiral lead. 482 of these 536 had pacing impedance measurements at 3 months and were included in the evaluation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NAVIGATE X4 Study Participants | Mean Pacing Impedance of ACUITY X4 Spiral Leads at 3 Months | 776 ohms |
Comparison: Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms
Secondary
Mean Pacing Impedance of RELIANCE 4-FRONT Active Fixation Leads at 3 Months
Pacing impedance measurements from RELIANCE 4-FRONT Active Fixation leads were collected at 3 months post-implant.
Time frame: 3 months
Population: Subjects eligible for analysis included the first 1507 subjects implanted/attempted with RELIANCE 4-FRONT active fixation lead. 1402 of these 1544 had pacing impedance measurements at 3 months and were included in the evaluation. Data were pooled with 2 other studies for official endpoint analysis. Only data from NAVIGATE X4 are presented here.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NAVIGATE X4 Study Participants | Mean Pacing Impedance of RELIANCE 4-FRONT Active Fixation Leads at 3 Months | 468 ohms |
Comparison: Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω90% CI: [463, 472]
Secondary
Mean Pacing Impedance of RELIANCE 4-FRONT Passive Fixation Leads at 3 Months
Pacing impedance measurements from RELIANCE 4-FRONT Passive Fixation leads were collected at 3 months post-implant.
Time frame: 3 months
Population: Subjects eligible for analysis included the first 37 subjects implanted/attempted with RELIANCE 4-FRONT passive fixation lead. 36 of these 37 had pacing impedance measurements at 3 months and were included in the evaluation. Data were pooled with 2 other studies for official endpoint analysis. Only data from NAVIGATE X4 are presented here.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NAVIGATE X4 Study Participants | Mean Pacing Impedance of RELIANCE 4-FRONT Passive Fixation Leads at 3 Months | 702 ohms |
Comparison: Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω90% CI: [659, 744]
Secondary
Mean Sensed Amplitude of ACUITY X4 Spiral Leads at 3 Months
Sensed amplitude measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.
Time frame: 3 months
Population: Subjects eligible for endpoint analysis included the first 536 subjects implanted/attempted with ACUITY X4 Spiral lead. 457 of these 536 had sensed amplitude measurements at 3 months and were included in the evaluation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NAVIGATE X4 Study Participants | Mean Sensed Amplitude of ACUITY X4 Spiral Leads at 3 Months | 17.4 millivolts (mV) |
Comparison: Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV
Secondary
Mean Sensed Amplitude of ACUITY X4 Straight Leads at 3 Months
Sensed amplitude measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.
Time frame: 3 months
Population: Subjects eligible for endpoint analysis included the first 228 subjects implanted/attempted with ACUITY X4 Straight lead. 189 of these 228 had sensed amplitude measurements at 3 months and were included in the evaluation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NAVIGATE X4 Study Participants | Mean Sensed Amplitude of ACUITY X4 Straight Leads at 3 Months | 16.1 millivolts (mV) |
Comparison: Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV
Secondary
Mean Sensed Amplitude of RELIANCE 4-FRONT Leads at 3 Months
Sensed amplitude measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant.
Time frame: 3 months
Population: Subjects eligible for endpoint analysis included the first 1544 subjects implanted/attempted with RELIANCE 4-FRONT lead. 1374 of these 1544 had sensed amplitude at 3 months and were included in the evaluation. Data were pooled with data from subjects from 2 other studies for official endpoint analysis. Only data from NAVIGATE X4 are presented here.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NAVIGATE X4 Study Participants | Mean Sensed Amplitude of RELIANCE 4-FRONT Leads at 3 Months | 18.3 millivolts (mV) |
Comparison: Ho: The 3-month mean sensed amplitude ≤ 5 mV, Ha: The 3-month mean sensed amplitude \> 5 mV
Secondary
Percentage of Successfully Converted Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads
Ventricular Tachyarrhythmia (VT/VF) Shock Conversion Efficacy, analyzed within 30 days of implant
Time frame: Within 30 days of implant
Population: Subjects eligible for endpoint analysis included the first 1544 subjects implanted/attempted with RELIANCE 4-FRONT lead. 560 of these 1544 had induced VT/VF episodes within 30 days of implant that were included in the evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVIGATE X4 Study Participants | Percentage of Successfully Converted Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads | 99.5 % of induced episodes |
Comparison: Ho: Percent of successful conversion ≤ 93%, Ha: Percent of successful conversion \> 93%