Trial Outcomes & Findings for Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads (NCT NCT02071173)

Results Overview

Lead-related complication-free rate of ACUITY X4 Spiral Leads from implant through 6 months post implant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2244 participants

Primary outcome timeframe

Implant through 6 months

Results posted on

2021-01-07

Participant Flow

Participants were not randomized to received a specific lead.

Participant milestones

Participant milestones
Measure	NAVIGATE X4 Study Participants All subjects that signed the informed consent were included. Subjects consent to undergo an implant procedure to receive at least one study device: ACUITY X4 LV lead, RELIANCE 4-FRONT RV lead. Each subject was allowed to be implanted with both leads. 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.
Overall Study STARTED	2244
Overall Study Implanted/Attempted With a Study Device	2200
Overall Study RELIANCE 4-FRONT Endpoint Population	1544
Overall Study ACUITY X4 Endpoint Population	764
Overall Study COMPLETED	409
Overall Study NOT COMPLETED	1835

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measurement not available on 3 subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NAVIGATE X4 Study Participants n=2244 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.
Age, Continuous	68.1 years STANDARD_DEVIATION 10.7 • n=2244 Participants
Sex: Female, Male Female	777 Participants n=2244 Participants
Sex: Female, Male Male	1467 Participants n=2244 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=2244 Participants
Race (NIH/OMB) Asian	22 Participants n=2244 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=2244 Participants
Race (NIH/OMB) Black or African American	292 Participants n=2244 Participants
Race (NIH/OMB) White	1791 Participants n=2244 Participants
Race (NIH/OMB) More than one race	8 Participants n=2244 Participants
Race (NIH/OMB) Unknown or Not Reported	129 Participants n=2244 Participants
Region of Enrollment United States	2244 participants n=2244 Participants
Left Ventricular Ejection Fraction (LVEF)	25.2 % STANDARD_DEVIATION 6.5 • n=2244 Participants
QRS duration	153 milliseconds STANDARD_DEVIATION 22 • n=2241 Participants • Measurement not available on 3 subjects
New York Heart Association (NYHA) Classification Class I	5 Participants n=2244 Participants
New York Heart Association (NYHA) Classification Class II	667 Participants n=2244 Participants
New York Heart Association (NYHA) Classification Class III	1485 Participants n=2244 Participants
New York Heart Association (NYHA) Classification Class IV	54 Participants n=2244 Participants
New York Heart Association (NYHA) Classification Non-Heart Failure Subject	6 Participants n=2244 Participants
New York Heart Association (NYHA) Classification Not available	27 Participants n=2244 Participants

PRIMARY outcome

Timeframe: Implant through 6 months

Population: This endpoint was limited to the first 536 subjects implanted/attempted with ACUITY X4 Spiral leads

Lead-related complication-free rate of ACUITY X4 Spiral Leads from implant through 6 months post implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=536 Participants Subjects enrolled in the NAVIGATE X4 Study
Percentage of ACUITY X4 Spiral Leads Free From Complication Through 6 Months	98.5 % of leads free from complication Interval 97.0 to One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 87%. It was pre-specified to only calculate the lower confidence interval.

PRIMARY outcome

Timeframe: Implant through 6 months

Population: This endpoint was limited to the first 228 subjects implanted/attempted with ACUITY X4 Straight leads

Lead-related complication-free rate of ACUITY X4 Straight Leads from implant through 6 months post implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=228 Participants Subjects enrolled in the NAVIGATE X4 Study
Percentage of ACUITY X4 Straight Leads Free From Complication Through 6 Months	96.5 % of leads free from complication Interval 93.8 to One-sided test was performed with 5% alpha. Lower one-sided 95% confidence limit was compared to performance goal of 85%. It was pre-specified to only calculate the lower confidence interval.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=685 Participants Subjects enrolled in the NAVIGATE X4 Study
Percentage of ACUITY X4 Leads With Acceptable Pacing Capture Thresholds (PCT)	94.0 % of leads with acceptable threshold Interval 92.0 to One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 75%. It was pre-specified to only calculate the lower confidence interval.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=484 Participants Subjects enrolled in the NAVIGATE X4 Study
Percentage of ACUITY X4 Spiral Leads With Acceptable Pacing Capture Thresholds (PCT) Using the Best Proximal Electrode	91.1 % of leads with acceptable threshold Interval 88.2 to One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 75%.It was pre-specified to only calculate the lower confidence interval.

PRIMARY outcome

Timeframe: 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.

Lead-related complication-free rate of RELIANCE 4-FRONT Leads from implant through 3 months post implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=1544 Participants Subjects enrolled in the NAVIGATE X4 Study
Percentage of RELIANCE 4-FRONT Leads Free From Complication Through 3 Months	98.2 % of leads free from complication Interval 97.5 to One-sided test was performed with 5% alpha. Lower one-sided 95% confidence limit was compared to performance goal of 93%. It was pre-specified to only calculate the lower confidence interval.

PRIMARY outcome

Timeframe: 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.

Lead-related complication-free rate of RELIANCE 4-FRONT Leads from 3 through 24 months post implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=1486 Participants Subjects enrolled in the NAVIGATE X4 Study
Percentage of RELIANCE 4-FRONT Leads Free From Complication From 3 Through 24 Months	99.3 % of leads free from complication Interval 98.8 to One-sided test was performed with 5% alpha. Lower one-sided 95% confidence limit was compared to performance goal of 94%. It was pre-specified to only calculate the lower confidence interval.

PRIMARY outcome

Timeframe: 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.

PCT measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant. Measurements were performed using 0.5 millisecond pulse width.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=1432 Participants Subjects enrolled in the NAVIGATE X4 Study
Mean Pacing Capture Threshold (PCT) of RELIANCE 4-FRONT Leads at 3 Months	0.56 Volts (V) Interval to 0.58 One-sided test was performed with 5% alpha. Upper one-sided 95% confidence limit was compared to performance goal of 1.5 Volts. It was pre-specified to only calculate the upper confidence interval.

SECONDARY outcome

Timeframe: 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.

Sensed amplitude measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=457 Participants Subjects enrolled in the NAVIGATE X4 Study
Mean Sensed Amplitude of ACUITY X4 Spiral Leads at 3 Months	17.4 millivolts (mV) Interval 16.7 to One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 3 mV. It was pre-specified to only calculate the lower confidence interval.

SECONDARY outcome

Timeframe: 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.

Sensed amplitude measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=189 Participants Subjects enrolled in the NAVIGATE X4 Study
Mean Sensed Amplitude of ACUITY X4 Straight Leads at 3 Months	16.1 millivolts (mV) Interval 15.1 to One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 85%. It was pre-specified to only calculate the lower confidence interval.

SECONDARY outcome

Timeframe: 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.

Pacing impedance measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=482 Participants Subjects enrolled in the NAVIGATE X4 Study
Mean Pacing Impedance of ACUITY X4 Spiral Leads at 3 Months	776 ohms Interval 753.0 to One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 300 ohms. It was pre-specified to only calculate the lower confidence interval.

SECONDARY outcome

Timeframe: 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.

Pacing impedance measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=202 Participants Subjects enrolled in the NAVIGATE X4 Study
Mean Pacing Impedance ACUITY X4 Straight Leads at 3 Months	805 ohms Interval 763.0 to One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 300 ohms. It was pre-specified to only calculate the lower confidence interval.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=557 Participants Subjects enrolled in the NAVIGATE X4 Study
Mean Detection Time of Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads	3.14 seconds Interval to 3.2 One-sided test was performed with 5% alpha. Upper one-sided 95% confidence limit was compared to performance goal of 4.5 seconds. It was pre-specified to only calculate the upper confidence interval.

SECONDARY outcome

Timeframe: 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.

Sensed amplitude measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=1374 Participants Subjects enrolled in the NAVIGATE X4 Study
Mean Sensed Amplitude of RELIANCE 4-FRONT Leads at 3 Months	18.3 millivolts (mV) Interval 17.9 to One-sided test was performed with 5% alpha. Lower one-sided 95% confidence limit was compared to performance goal of 5 mV seconds. It was pre-specified to only calculate the lower confidence interval.

SECONDARY outcome

Timeframe: 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.

Pacing impedance measurements from RELIANCE 4-FRONT Active Fixation leads were collected at 3 months post-implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=1402 Participants Subjects enrolled in the NAVIGATE X4 Study
Mean Pacing Impedance of RELIANCE 4-FRONT Active Fixation Leads at 3 Months	468 ohms Interval 463.0 to 472.0

SECONDARY outcome

Timeframe: 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.

Pacing impedance measurements from RELIANCE 4-FRONT Passive Fixation leads were collected at 3 months post-implant.

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=36 Participants Subjects enrolled in the NAVIGATE X4 Study
Mean Pacing Impedance of RELIANCE 4-FRONT Passive Fixation Leads at 3 Months	702 ohms Interval 659.0 to 744.0

SECONDARY outcome

Timeframe: 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.

Ventricular Tachyarrhythmia (VT/VF) Shock Conversion Efficacy, analyzed within 30 days of implant

Outcome measures

Outcome measures
Measure	NAVIGATE X4 Study Participants n=560 Participants Subjects enrolled in the NAVIGATE X4 Study
Percentage of Successfully Converted Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads	99.5 % of induced episodes Interval 98.4 to One-sided test was performed with 5% alpha. Lower one-sided 95% confidence limit was compared to performance goal of 93%. It was pre-specified to only calculate the lower confidence interval.

Adverse Events

NAVIGATE X4 Study Participants

Serious events: 1539 serious events

Other events: 1768 other events

Deaths: 491 deaths

Serious adverse events

Serious adverse events
Measure	NAVIGATE X4 Study Participants n=2200 participants at risk All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200). Adverse events were not collected based on the lead implanted in the subject. All subjects were implanted or attempted with a CRT-D, Individual adverse event categories evaluated in participants at risk for that event category (2007 implanted/attempted with RA lead, 2090 with 4-FRONT, 2199 with any RV lead, 2162 with ACUITY X4, 2182 with any LV lead, 2019 with ACUITY X4 and/or 4-FRONT, 2019 with any lead).
Cardiac disorders Cardiovascular - Heart Failure	28.2% 620/2200 • Number of events 1256 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Cardiac disorders Cardiovascular - Non-Heart Failure	37.7% 829/2200 • Number of events 1431 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
General disorders Non-Cardiovascular	47.4% 1043/2200 • Number of events 2581 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues Pulse Generator	3.4% 74/2200 • Number of events 80 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues RA Lead	1.4% 28/2007 • Number of events 29 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues RV Lead - Related to RELIANCE 4-FRONT	2.2% 45/2090 • Number of events 46 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues RV Lead - Unrelated to / Not caused by RELIANCE 4-FRONT	0.27% 6/2199 • Number of events 6 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues LV Lead - Related to ACUITY X4	1.1% 24/2162 • Number of events 24 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues LV Lead - Unrelated to / Not caused by ACUITY X4	0.41% 9/2182 • Number of events 9 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues RV & LV Lead - Related to both RELIANCE 4-FRONT and ACUITY X4	0.14% 3/2109 • Number of events 3 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues Lead - Other	0.79% 16/2019 • Number of events 17 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Surgical and medical procedures Procedure-related	4.9% 107/2200 • Number of events 117 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Investigations Unclassified	0.23% 5/2200 • Number of events 5 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).

Other adverse events

Other adverse events
Measure	NAVIGATE X4 Study Participants n=2200 participants at risk All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200). Adverse events were not collected based on the lead implanted in the subject. All subjects were implanted or attempted with a CRT-D, Individual adverse event categories evaluated in participants at risk for that event category (2007 implanted/attempted with RA lead, 2090 with 4-FRONT, 2199 with any RV lead, 2162 with ACUITY X4, 2182 with any LV lead, 2019 with ACUITY X4 and/or 4-FRONT, 2019 with any lead).
Cardiac disorders Cardiovascular - Heart Failure	24.7% 543/2200 • Number of events 838 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Cardiac disorders Cardiovascular - Non-Heart Failure	50.2% 1105/2200 • Number of events 2358 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
General disorders Non-Cardiovascular	61.0% 1341/2200 • Number of events 5430 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues Pulse Generator	11.9% 262/2200 • Number of events 328 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues RA Lead	2.1% 43/2007 • Number of events 47 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues RV Lead - Related to RELIANCE 4-FRONT	2.0% 41/2090 • Number of events 46 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues RV Lead - Unrelated to / Not caused by RELIANCE 4-FRONT	0.18% 4/2199 • Number of events 4 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues LV Lead - Related to ACUITY X4	12.5% 271/2162 • Number of events 322 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues LV Lead - Unrelated to / Not caused by ACUITY X4	0.41% 9/2182 • Number of events 9 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues RV & LV Lead - Related to both RELIANCE 4-FRONT and ACUITY X4	0.38% 8/2109 • Number of events 8 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Product Issues Lead - Other	0.28% 6/2109 • Number of events 6 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Surgical and medical procedures Procedure-related	13.5% 297/2200 • Number of events 350 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).
Investigations Unclassified	0.36% 8/2200 • Number of events 9 • Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years). All adverse events (serious/non-serious, related/unrelated to device) were to be reported to Boston Scientific by the investigational sites. All-cause mortality evaluated in all enrolled participants (N = 2244). Adverse events evaluated in participants implanted or attempted with ACUITY X4 and/or RELIANCE 4-FRONT (N = 2200).

Additional Information

Kelly Aspinwall

Boston Scientific

Phone: 1-800-CARDIAC

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place