NAVIGATE X4: Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02071173
• Collaborator: (none)
• Enrollment: 2,244
• Locations: 96
• Arm: 1
• Actual Duration (Months): 77.8
• Patients Per Site: 23.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Resynchronization Therapy	Device: ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2244 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Every subject had access to two study devices and were followed as a single group.Every subject had access to two study devices and were followed as a single group.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads: NAVIGATE X4
• Actual Study Start Date: Apr 14, 2014
• Actual Primary Completion Date: Apr 19, 2017
• Actual Study Completion Date: Oct 6, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Enrolled Patients Subjects undergo an implant procedure to receive at least one investigational lead -- ACUITY X4 left ventricular (LV) CRT lead, RELIANCE 4-FRONT right ventricular (RV) ICD lead

Device: ACUITY 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.; Other Names: LV Quadripolar coronary venous lead RV defibrillation Lead

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

1. AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Huntsville Hospital	Huntsville	Alabama	United States	35801
3	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
4	Banner Baywood Heart Hospital	Mesa	Arizona	United States	85206
5	Scottsdale Healthcare - Osborn	Scottsdale	Arizona	United States	85258
6	Cardiology Associates of Northeast Arkansas, P.A.	Jonesboro	Arkansas	United States	72401
7	Kaiser Permanente	Los Angeles	California	United States	90027
8	USC Medical Center	Los Angeles	California	United States	90033
9	Alta Bates Medical Center	Oakland	California	United States	94609
10	Mercy General Hospital	Sacramento	California	United States	95819
11	Sharp Memorial Hospital	San Diego	California	United States	92123
12	Hartford Hospital	Hartford	Connecticut	United States	06102
13	Yale University School of Medicine	New Haven	Connecticut	United States	06510
14	Delray Medical Center	Fort Lauderdale	Florida	United States	33334
15	Lakeland Regional Medical Center	Lakeland	Florida	United States	38805
16	West Florida Cardiology Network, LLC	Largo	Florida	United States	33770
17	Tallahassee Memorial Hospital	Tallahassee	Florida	United States	32308
18	Tampa General Hospital	Tampa	Florida	United States	33606
19	Emory University Hospital	Atlanta	Georgia	United States	30308
20	Gwinnett Hospital System Inc.	Lawrenceville	Georgia	United States	30046
21	University of Chicago	Chicago	Illinois	United States	60637
22	Alexian Brothers Medical Center	Elk Grove Village	Illinois	United States	60007
23	St. John's Hospital	Springfield	Illinois	United States	62769
24	Porter Memorial Hospital	Dyer	Indiana	United States	46311
25	Lutheran Medical Group	Fort Wayne	Indiana	United States	48804
26	St. Vincent's Hospital	Indianapolis	Indiana	United States	46260
27	Ball Memorial Hospital	Muncie	Indiana	United States	47303
28	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
29	University of Kansas Hospital	Kansas City	Kansas	United States	66160
30	Baptist Health Lexington	Lexington	Kentucky	United States	40503
31	University of Louisville Hospital	Louisville	Kentucky	United States	40202
32	Eastern Maine Medical Center	Bangor	Maine	United States	04401
33	Union Memorial Hospital	Baltimore	Maryland	United States	21237
34	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
35	Spectrum Health Hospitals	Grand Rapids	Michigan	United States	49503
36	St. Joseph Mercy Hospital	Ypsilanti	Michigan	United States	48197
37	St. Mary's Duluth Clinic Regional Heart Center	Duluth	Minnesota	United States	55805
38	St. Cloud Hospital	Saint Cloud	Minnesota	United States	56303
39	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota	United States	55102
40	United Heart and Vascular Clinic	Saint Paul	Minnesota	United States	55102
41	Boone Hospital Center	Columbia	Missouri	United States	65201
42	St. Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
43	Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110
44	Cox Health	Springfield	Missouri	United States	65807
45	Nebraska Heart Institute	Lincoln	Nebraska	United States	68526
46	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
47	Cooper Hospital - University Medical Center	Haddon Heights	New Jersey	United States	08035
48	Jersey Shore University Medical Center	Neptune	New Jersey	United States	07753
49	Valley Hospital	Ridgewood	New Jersey	United States	07450
50	Montefiore Medical Center	Bronx	New York	United States	10467
51	Maimonides Medical Center	Brooklyn	New York	United States	11219
52	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
53	Columbia University Medical Center	New York	New York	United States	10032
54	Stony Brook University Hospital	Stony Brook	New York	United States	11794
55	Buffalo General Hospital	Williamsville	New York	United States	14221
56	Mercy Hospital of Buffalo, Catholic Health System	Williamsville	New York	United States	14221
57	University of North Carolina Hospital	Chapel Hill	North Carolina	United States	27599
58	Duke University Medical Center	Durham	North Carolina	United States	27710
59	Aultman Hospital	Canton	Ohio	United States	44710
60	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
61	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
62	Ohio State University Medical Center	Columbus	Ohio	United States	43210
63	OhioHealth Research and Innovation Institute - Riverside Methodist Hospital	Columbus	Ohio	United States	43214
64	Wheeling Hospital Inc.	Steubenville	Ohio	United States	43952
65	The Toledo Hospital	Toledo	Ohio	United States	43615
66	Asante Rogue Regional Medical Center	Medford	Oregon	United States	97504
67	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
68	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
69	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
70	York Hospital	York	Pennsylvania	United States	17403
71	Medical University of South Carolina	Charleston	South Carolina	United States	29425
72	PeeDee Cardiology Associates PA	Florence	South Carolina	United States	29506
73	Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
74	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
75	Avera Heart Hospital of South Dakota	Sioux Falls	South Dakota	United States	57108
76	Stern Cardiovascular Foundation, Inc.	Germantown	Tennessee	United States	38138
77	St. Thomas Research Institute, LLC	Nashville	Tennessee	United States	37205
78	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37215
79	Texas Cardiac Arrhythmia Research	Austin	Texas	United States	78705
80	Heart Hospital of Austin	Austin	Texas	United States	78756
81	SouthEast Texas Clinical Research Center	Beaumont	Texas	United States	77702
82	Medical City Dallas Hospital	Dallas	Texas	United States	75230
83	Walnut Hill Medical Center	Dallas	Texas	United States	75231
84	Plaza Medical Center of Fort Worth	Fort Worth	Texas	United States	76104
85	University of Texas Houston Health Science Center	The Woodlands	Texas	United States	77384
86	Trinity Mother Frances Health System	Tyler	Texas	United States	75701
87	Intermountain Medical Center	Murray	Utah	United States	84107
88	Bon Secours Heart & Vascular Institute	Mechanicsville	Virginia	United States	23116
89	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
90	Virginia Cardiovascular Specialist	Richmond	Virginia	United States	23225
91	PeaceHealth St. Joseph Medical Center	Bellingham	Washington	United States	98225
92	Providence Regional Medical Center Everett	Everett	Washington	United States	98201
93	Kootenai Heart Clinics	Spokane	Washington	United States	99204
94	Providence Health & Services - Washington	Spokane	Washington	United States	99204
95	Charleston Area Medical Center	Charleston	West Virginia	United States	25304
96	Monongalia General Hospital	Morgantown	West Virginia	United States	26505

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Suneet Mittal, MD, The Valley Hospital
• Principal Investigator: Martin Burke, DO, University of Chicago

Study Documents (Full-Text)

• Statistical Analysis Plan - Feb 25, 2015
• Study Protocol - Dec 17, 2013

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02071173
• Other Study ID Numbers: C1481
• First Posted: Feb 25, 2014
• Last Update Posted: Jan 7, 2021
• Last Verified: Dec 1, 2020

Study Results

Participant Flow

Pre-assignment Detail	Participants were not randomized to received a specific lead.

Arm/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	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.
Period Title: Overall Study
STARTED	2244
Implanted/Attempted With a Study Device	2200
RELIANCE 4-FRONT Endpoint Population	1544
ACUITY X4 Endpoint Population	764
COMPLETED	409
NOT COMPLETED	1835

Baseline Characteristics

Arm/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	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.
Overall Participants	2244
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.1 (10.7)
Sex: Female, Male (Count of Participants)
Female	777 34.6%
Male	1467 65.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	22 1%
Native Hawaiian or Other Pacific Islander	2 0.1%
Black or African American	292 13%
White	1791 79.8%
More than one race	8 0.4%
Unknown or Not Reported	129 5.7%
Region of Enrollment (participants) [Number]
United States	2244 100%
Left Ventricular Ejection Fraction (LVEF) (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	25.2 (6.5)
QRS duration (milliseconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milliseconds]	153 (22)
New York Heart Association (NYHA) Classification (Count of Participants)
Class I	5 0.2%
Class II	667 29.7%
Class III	1485 66.2%
Class IV	54 2.4%
Non-Heart Failure Subject	6 0.3%
Not available	27 1.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of ACUITY X4 Spiral Leads Free From Complication Through 6 Months
Description	Lead-related complication-free rate of ACUITY X4 Spiral Leads from implant through 6 months post implant.
Time Frame	Implant through 6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	536
Number (97.5% Confidence Interval) [% of leads free from complication]	98.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The Implant through 6-month lead-related complication-free rate ≤ 87%, Ha: The Implant through 6-month lead-related complication-free rate > 87%
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 87%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent
	Estimated Value	98.5
	Confidence Interval	(1-Sided) 97.5%; 97.0 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of ACUITY X4 Straight Leads Free From Complication Through 6 Months
Description	Lead-related complication-free rate of ACUITY X4 Straight Leads from implant through 6 months post implant.
Time Frame	Implant through 6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	228
Number (95% Confidence Interval) [% of leads free from complication]	96.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The Implant through 6-month lead-related complication-free rate ≤ 85%, Ha: The Implant through 6-month lead-related complication-free rate > 85%
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 85%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent
	Estimated Value	96.5
	Confidence Interval	(1-Sided) 95%; 93.8 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Percentage of ACUITY X4 Leads With Acceptable Pacing Capture Thresholds (PCT)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	685
Number (97.5% Confidence Interval) [% of leads with acceptable threshold]	94.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V > 75%
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent
	Estimated Value	94.0
	Confidence Interval	(1-Sided) 97.5%; 92.0 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Percentage of ACUITY X4 Spiral Leads With Acceptable Pacing Capture Thresholds (PCT) Using the Best Proximal Electrode
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	484
Number (97.5% Confidence Interval) [% of leads with acceptable threshold]	91.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V > 75%
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent
	Estimated Value	91.1
	Confidence Interval	(1-Sided) 97.5%; 88.2 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	Percentage of RELIANCE 4-FRONT Leads Free From Complication Through 3 Months
Description	Lead-related complication-free rate of RELIANCE 4-FRONT Leads from implant through 3 months post implant.
Time Frame	Implant through 3 months

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	1544
Number (95% Confidence Interval) [% of leads free from complication]	98.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The Implant through 3-month lead-related complication-free rate ≤ 93%, Ha: The Implant through 3-month lead-related complication-free rate > 93%
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent
	Estimated Value	98.2
	Confidence Interval	(1-Sided) 95%; 97.5 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	Percentage of RELIANCE 4-FRONT Leads Free From Complication From 3 Through 24 Months
Description	Lead-related complication-free rate of RELIANCE 4-FRONT Leads from 3 through 24 months post implant.
Time Frame	3 months through 24 months

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	1486
Number (95% Confidence Interval) [% of leads free from complication]	99.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The 3- through 24-month lead-related complication-free rate ≤ 94%, Ha: The 3- through 24-month lead-related complication-free rate > 94%
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 94%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent
	Estimated Value	99.3
	Confidence Interval	(1-Sided) 95%; 98.8 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	Mean Pacing Capture Threshold (PCT) of RELIANCE 4-FRONT Leads at 3 Months
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	1432
Mean (95% Confidence Interval) [Volts (V)]	0.56

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The 3-month mean PCT ≥ 1.5 Volts, Ha: The 3-month mean PCT < 1.5 Volts
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 1.5 Volts. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	0.56
	Confidence Interval	(1-Sided) 95%; to 0.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Mean Sensed Amplitude of ACUITY X4 Spiral Leads at 3 Months
Description	Sensed amplitude measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	457
Mean (97.5% Confidence Interval) [millivolts (mV)]	17.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude > 3 mV
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	17.4
	Confidence Interval	(1-Sided) 95%; 16.7 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Mean Sensed Amplitude of ACUITY X4 Straight Leads at 3 Months
Description	Sensed amplitude measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	189
Mean (97.5% Confidence Interval) [millivolts (mV)]	16.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude > 3 mV
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	16.1
	Confidence Interval	(1-Sided) 97.5%; 15.1 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Mean Pacing Impedance of ACUITY X4 Spiral Leads at 3 Months
Description	Pacing impedance measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	482
Mean (97.5% Confidence Interval) [ohms]	776

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance > 300 ohms
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	776
	Confidence Interval	(1-Sided) 97.5%; 753 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Mean Pacing Impedance ACUITY X4 Straight Leads at 3 Months
Description	Pacing impedance measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	202
Mean (97.5% Confidence Interval) [ohms]	805

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance > 300 ohms
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	805
	Confidence Interval	(1-Sided) 97.5%; 763 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Mean Detection Time of Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	557
Number (95% Confidence Interval) [seconds]	3.14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The mean detection time ≥ 4.5 seconds, Ha: The mean detection time < 4.5 seconds
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 4.5 seconds. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	3.14
	Confidence Interval	(1-Sided) 95%; to 3.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Mean Sensed Amplitude of RELIANCE 4-FRONT Leads at 3 Months
Description	Sensed amplitude measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	1374
Mean (95% Confidence Interval) [millivolts (mV)]	18.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: The 3-month mean sensed amplitude ≤ 5 mV, Ha: The 3-month mean sensed amplitude > 5 mV
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 5 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	18.3
	Confidence Interval	(1-Sided) 95%; 6.2 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Mean Pacing Impedance of RELIANCE 4-FRONT Active Fixation Leads at 3 Months
Description	Pacing impedance measurements from RELIANCE 4-FRONT Active Fixation leads were collected at 3 months post-implant.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	1402
Mean (90% Confidence Interval) [ohms]	468

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω < Pacing impedance < 1200 Ω
	Type of Statistical Test	Other
	Comments	Two one-sided tests (TOST) were performed.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	468
	Confidence Interval	(2-Sided) 90%; 463 to 472
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Mean Pacing Impedance of RELIANCE 4-FRONT Passive Fixation Leads at 3 Months
Description	Pacing impedance measurements from RELIANCE 4-FRONT Passive Fixation leads were collected at 3 months post-implant.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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/Group Title	RELIANCE 4-FRONT LEAD
Arm/Group Description	RELIANCE 4-FRONT Endpoint Population
Measure Participants	36
Mean (90% Confidence Interval) [ohms]	702

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω < Pacing impedance < 1200 Ω
	Type of Statistical Test	Other
	Comments	Two one-sided tests (TOST) were performed.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	702
	Confidence Interval	(2-Sided) 90%; 659 to 744
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Percentage of Successfully Converted Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads
Description	Ventricular Tachyarrhythmia (VT/VF) Shock Conversion Efficacy, analyzed within 30 days of implant
Time Frame	Within 30 days of implant

Outcome Measure Data

Analysis Population Description

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/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	Subjects enrolled in the NAVIGATE X4 Study
Measure Participants	560
Number (95% Confidence Interval) [% of induced episodes]	99.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVIGATE X4 Study Participants
	Comments	Ho: Percent of successful conversion ≤ 93%, Ha: Percent of successful conversion > 93%
	Type of Statistical Test	Superiority
	Comments	Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent
	Estimated Value	99.5
	Confidence Interval	(1-Sided) 95%; 98.4 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years).
Adverse Event Reporting Description	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).
Arm/Group Title	NAVIGATE X4 Study Participants
Arm/Group Description	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).
All Cause Mortality
	NAVIGATE X4 Study Participants
	Affected / at Risk (%)	# Events
Total	491/2244 (21.9%)
Serious Adverse Events
	NAVIGATE X4 Study Participants
	Affected / at Risk (%)	# Events
Total	1539/2200 (70%)
Cardiac disorders
Cardiovascular - Heart Failure	620/2200 (28.2%)	1256
Cardiovascular - Non-Heart Failure	829/2200 (37.7%)	1431
General disorders
Non-Cardiovascular	1043/2200 (47.4%)	2581
Investigations
Unclassified	5/2200 (0.2%)	5
Product Issues
Pulse Generator	74/2200 (3.4%)	80
RA Lead	28/2007 (1.4%)	29
RV Lead - Related to RELIANCE 4-FRONT	45/2090 (2.2%)	46
RV Lead - Unrelated to / Not caused by RELIANCE 4-FRONT	6/2199 (0.3%)	6
LV Lead - Related to ACUITY X4	24/2162 (1.1%)	24
LV Lead - Unrelated to / Not caused by ACUITY X4	9/2182 (0.4%)	9
RV & LV Lead - Related to both RELIANCE 4-FRONT and ACUITY X4	3/2109 (0.1%)	3
Lead - Other	16/2019 (0.8%)	17
Surgical and medical procedures
Procedure-related	107/2200 (4.9%)	117
Other (Not Including Serious) Adverse Events
	NAVIGATE X4 Study Participants
	Affected / at Risk (%)	# Events
Total	1768/2200 (80.4%)
Cardiac disorders
Cardiovascular - Heart Failure	543/2200 (24.7%)	838
Cardiovascular - Non-Heart Failure	1105/2200 (50.2%)	2358
General disorders
Non-Cardiovascular	1341/2200 (61%)	5430
Investigations
Unclassified	8/2200 (0.4%)	9
Product Issues
Pulse Generator	262/2200 (11.9%)	328
RA Lead	43/2007 (2.1%)	47
RV Lead - Related to RELIANCE 4-FRONT	41/2090 (2%)	46
RV Lead - Unrelated to / Not caused by RELIANCE 4-FRONT	4/2199 (0.2%)	4
LV Lead - Related to ACUITY X4	271/2162 (12.5%)	322
LV Lead - Unrelated to / Not caused by ACUITY X4	9/2182 (0.4%)	9
RV & LV Lead - Related to both RELIANCE 4-FRONT and ACUITY X4	8/2109 (0.4%)	8
Lead - Other	6/2109 (0.3%)	6
Surgical and medical procedures
Procedure-related	297/2200 (13.5%)	350

Limitations/Caveats

Data as of 5-Feb-2020. Follow-up is ongoing.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.