Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Lead... | NCT02071173

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enrolled Patients	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Implant through 6 months
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.	Implant through 6 months
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.	Implant through 3 months
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.	3 months
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.	Implant through 3 months
Percentage of RELIANCE 4-FRONT Leads Free From Complication From 3 Through 24 Months

Secondary Outcomes

Measure	Description	Time Frame
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.	3 months
Mean Sensed Amplitude of ACUITY X4 Straight Leads at 3 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects indicated for a CRT-D that fulfill one of the following 5 criteria[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)*
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*
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*
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
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.

Name	Affiliation	Role
Suneet Mittal, MD	The Valley Hospital	Principal Investigator
Martin Burke, DO	University of Chicago	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Huntsville Hospital

PubMed Identifier	Type	Citation	Retractions
27434039	Derived	Mittal S, Nair D, Padanilam BJ, Ciuffo A, Gupta N, Gallagher P, Goldner B, Hammill EF, Wold N, Stein K, Burke M. Performance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial. J Cardiovasc Electrophysiol. 2016 Oct;27(10):1199-1205. doi: 10.1111/jce.13044. Epub 2016 Aug 19.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Feb 25, 2015	Sep 9, 2019

Arm/Group Information

ID	Title	Description
BG000	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.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

- ParticipantsBG0002244

Title	Measurements
	BG00068.1± 10.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG0002244

Title	Measurements
Female	BG000777
Male

Race (NIH/OMB)

Racial and Ethnic Categories and Definitions consistent with those used for National Institutes of Health (NIH) Diversity Programs/Other Reporting Purposes and with the Standards for the Classification of Federal Data on Race and Ethnicity issued by the Office of Management and Budget (OMB).

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG0002244

Title	Measurements
American Indian or Alaska Native	BG000

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

- ParticipantsBG0002244

Title	Measurements
	BG0002244

Left Ventricular Ejection Fraction (LVEF)

Mean

Standard Deviation

Title

Denominators

Categories

- ParticipantsBG0002244

Title	Measurements
	BG00025.2± 6.5

QRS duration

The QRS duration represents the time for ventricular depolarization (activation), starting at the Q wave and ending at the S wave, as measured from an electrocardiogram (ECG). Q waves are inscribed when the initial QRS vector is directed away from the positive electrode. The R wave is the first positive deflection of the QRS complex. The negative deflection after the R wave is the S wave.

Measurement not available on 3 subjects

Mean

Standard Deviation

milliseconds

Title

Denominators

Categories

- ParticipantsBG0002241

Title	Measurements
	BG000

New York Heart Association (NYHA) Classification

NYHA Classification of severity of heart failure places subjects in 1 of 4 categories based on how much they are limited during physical activity, based on physician assessment.

Class I = normal function status, Class II = Slight limitation of functional status, Class III = Marked limitation of functional status, Class IV = Severe limitation of functional status.

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG0002244

Title	Measurements
Class I	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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

Posted

Number

97.5% Confidence Interval

% of leads free from complication

Implant through 6 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000536

Title

Denominators

Categories

Title	Measurements
	OG00098.5(97.0 to NA)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.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Ho: The Implant through 6-month lead-related complication-free rate ≤ 87%, Ha: The Implant through 6-month lead-related complication-free rate > 87%					Percent	98.5			1-Sided	97.5	97.0						Superiority	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.

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.

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

Posted

Number

95% Confidence Interval

% of leads free from complication

Implant through 6 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000228

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.

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.

Posted

Number

97.5% Confidence Interval

% of leads with acceptable threshold

Implant through 3 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Number

97.5% Confidence Interval

% of leads with acceptable threshold

3 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Number

95% Confidence Interval

% of leads free from complication

Implant through 3 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Number

95% Confidence Interval

% of leads free from complication

3 months through 24 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Mean

95% Confidence Interval

Volts (V)

Implant through 3 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Mean

97.5% Confidence Interval

millivolts (mV)

3 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Mean

97.5% Confidence Interval

millivolts (mV)

3 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Mean

97.5% Confidence Interval

ohms

3 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Mean

97.5% Confidence Interval

ohms

3 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Number

95% Confidence Interval

seconds

Within 30 days of implant

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Mean

95% Confidence Interval

millivolts (mV)

3 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Mean

90% Confidence Interval

ohms

3 months

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

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.

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.

Posted

Mean

90% Confidence Interval

ohms

3 months

ID	Title	Description
OG000	RELIANCE 4-FRONT LEAD	RELIANCE 4-FRONT Endpoint Population

Units	Counts
Participants	OG000

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

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.

Posted

Number

95% Confidence Interval

% of induced episodes

Within 30 days of implant

ID	Title	Description
OG000	NAVIGATE X4 Study Participants	Subjects enrolled in the NAVIGATE X4 Study

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Cardiovascular - Heart Failure	Cardiac disorders	Non-systematic Assessment	EG0001,256 events620 affected2,200 at risk
Cardiovascular - Non-Heart Failure	Cardiac disorders	Non-systematic Assessment	EG0001,431 events829 affected2,200 at risk
Non-Cardiovascular	General disorders	Non-systematic Assessment	EG0002,581 events1,043 affected2,200 at risk
Pulse Generator	Product Issues	Non-systematic Assessment	EG00080 events74 affected2,200 at risk
RA Lead	Product Issues	Non-systematic Assessment	EG00029 events28 affected2,007 at risk
RV Lead - Related to RELIANCE 4-FRONT	Product Issues	Non-systematic Assessment	EG00046 events45 affected2,090 at risk
RV Lead - Unrelated to / Not caused by RELIANCE 4-FRONT	Product Issues	Non-systematic Assessment	EG0006 events6 affected2,199 at risk
LV Lead - Related to ACUITY X4	Product Issues	Non-systematic Assessment	EG00024 events24 affected2,162 at risk
LV Lead - Unrelated to / Not caused by ACUITY X4	Product Issues	Non-systematic Assessment	EG0009 events9 affected2,182 at risk
RV & LV Lead - Related to both RELIANCE 4-FRONT and ACUITY X4	Product Issues	Non-systematic Assessment	EG0003 events3 affected2,109 at risk
Lead - Other	Product Issues	Non-systematic Assessment	EG00017 events16 affected2,019 at risk
Procedure-related	Surgical and medical procedures	Non-systematic Assessment	EG000117 events107 affected2,200 at risk
Unclassified	Investigations	Non-systematic Assessment	EG0005 events5 affected2,200 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Cardiovascular - Heart Failure	Cardiac disorders	Non-systematic Assessment	EG000838 events543 affected2,200 at risk
Cardiovascular - Non-Heart Failure	Cardiac disorders	Non-systematic Assessment	EG0002,358 events1,105 affected2,200 at risk
Non-Cardiovascular	General disorders	Non-systematic Assessment	EG0005,430 events1,341 affected2,200 at risk
Pulse Generator	Product Issues	Non-systematic Assessment	EG000328 events262 affected2,200 at risk
RA Lead	Product Issues	Non-systematic Assessment	EG00047 events43 affected2,007 at risk
RV Lead - Related to RELIANCE 4-FRONT	Product Issues	Non-systematic Assessment	EG00046 events41 affected2,090 at risk
RV Lead - Unrelated to / Not caused by RELIANCE 4-FRONT	Product Issues	Non-systematic Assessment	EG0004 events4 affected2,199 at risk
LV Lead - Related to ACUITY X4	Product Issues	Non-systematic Assessment	EG000322 events271 affected2,162 at risk
LV Lead - Unrelated to / Not caused by ACUITY X4	Product Issues	Non-systematic Assessment	EG0009 events9 affected2,182 at risk
RV & LV Lead - Related to both RELIANCE 4-FRONT and ACUITY X4	Product Issues	Non-systematic Assessment	EG0008 events8 affected2,109 at risk
Lead - Other	Product Issues	Non-systematic Assessment	EG0006 events6 affected2,109 at risk
Procedure-related	Surgical and medical procedures	Non-systematic Assessment	EG000350 events297 affected2,200 at risk
Unclassified	Investigations	Non-systematic Assessment	EG0009 events8 affected2,200 at risk