Trial Outcomes & Findings for Managed Ventricular Pacing ("MVP") Trial (NCT NCT00281099)

NCT ID: NCT00281099

Last Updated: 2010-08-03

Results Overview

A composite endpoint of all cause mortality and HF hospitalizations or urgent care. (Emergency Department, Urgent Clinic visits, or hospitalizations wiht intravenous medications for HF)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1031 participants
• Primary outcome timeframe: Enrollment to last visit (up to 45 months post-randomization) or death
• Results posted on: 2010-08-03

Participant Flow

2051 subjects were screened for the study. Of the 2051 subjects screened, 1037 were enrolled in the study. 6 of 1037 subjects later failed to meet other qualifying inclusion criteria and were not randomized and assigned to a study arm.

Participant milestones

Measure	VVI 40 Pacing Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing Managed Ventricular Pacing at a rate of 60 beats per minute
Overall Study STARTED	513	518
Overall Study COMPLETED	308	296
Overall Study NOT COMPLETED	205	222

Reasons for withdrawal

Measure	VVI 40 Pacing Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing Managed Ventricular Pacing at a rate of 60 beats per minute
Overall Study Death	46	57
Overall Study Lost to Follow-up	10	19
Overall Study Withdrawal by Subject	65	70
Overall Study Physician Decision	79	72
Overall Study Heart Transplant/Device Exit/Changeout	5	4

Baseline Characteristics

Managed Ventricular Pacing ("MVP") Trial

Baseline characteristics by cohort

Measure	VVI 40 Pacing n=513 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute	Total n=1031 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	289 Participants n=5 Participants	284 Participants n=7 Participants	573 Participants n=5 Participants
Age, Categorical >=65 years	224 Participants n=5 Participants	234 Participants n=7 Participants	458 Participants n=5 Participants
Age Continuous	61.7 years STANDARD_DEVIATION 11.7 • n=5 Participants	62.6 years STANDARD_DEVIATION 12.0 • n=7 Participants	62.2 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	104 Participants n=7 Participants	212 Participants n=5 Participants
Sex: Female, Male Male	405 Participants n=5 Participants	414 Participants n=7 Participants	819 Participants n=5 Participants
Region of Enrollment France	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment United States	390 participants n=5 Participants	390 participants n=7 Participants	780 participants n=5 Participants
Region of Enrollment Canada	58 participants n=5 Participants	60 participants n=7 Participants	118 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Austria	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Denmark	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Israel	14 participants n=5 Participants	15 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment Germany	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment United Kingdom	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Switzerland	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment Italy	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment to last visit (up to 45 months post-randomization) or death

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

A composite endpoint of all cause mortality and HF hospitalizations or urgent care. (Emergency Department, Urgent Clinic visits, or hospitalizations wiht intravenous medications for HF)

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure ("HF") Hospitalizations.	167 events	188 events

SECONDARY outcome

Timeframe: Enrollment to last visit (up to 45 months post-randomization)

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

HF event meeting primary endpoint definition, or adverse events associated with, but not limited to, any of the following: symptoms or physical signs compatible with worsening HF, laboratory evidence of HF, any modification of oral heart failure therapy

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Occurrence of Worsening Heart Failure-related Adverse Events Number of Participants with Events	96 participants/events	108 participants/events
Occurrence of Worsening Heart Failure-related Adverse Events Number of Events	193 participants/events	190 participants/events

SECONDARY outcome

Timeframe: Baseline, 12, 24 and 36 month visits

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time Baseline NYHA I	140 participants	122 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time Baseline NYHA II	271 participants	293 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time Baseline NYHA III	93 participants	98 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time Baseline NYHA IV	1 participants	1 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time Baseline NYHA Obtained Outside Window	7 participants	4 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 12 Month NYHA I	139 participants	118 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 12 Month NYHA II	242 participants	234 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 12 Month NYHA III	46 participants	55 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 12 Month NYHA IV	5 participants	1 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 12 Month NYHA Missing due to Death	21 participants	22 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 12 Month NYHA Missing For Other Reasons	59 participants	88 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 24 Month NYHA I	119 participants	104 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 24 Month NYHA II	205 participants	197 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 24 Month NYHA III	44 participants	44 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 24 Month NYHA IV	2 participants	4 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 24 Month NYHA Missing due to Death	39 participants	40 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 24 Month NYHA Missing For Other Reasons	103 participants	129 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 36 Month NYHA I	18 participants	23 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 36 Month NYHA II	46 participants	42 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 36 Month NYHA III	8 participants	7 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 36 Month NYHA IV	1 participants	1 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 36 Month NYHA Missing due to Death	46 participants	57 participants
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time 36 Month NYHA Missing For Other Reasons	393 participants	388 participants

SECONDARY outcome

Timeframe: Baseline, 12, and 24 month visits

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Echocardiogram measures for each endpoint were obtained at multiple time points.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Heart Chamber Dimensions and Wall Thicknesses Posterior Wall Thickness (cm) at 24 Months	1 centimeters (cm) Standard Deviation 0.2	1 centimeters (cm) Standard Deviation 0.2
Heart Chamber Dimensions and Wall Thicknesses LV End Systolic Dimension (LVESD) (cm) at Baseline	4.9 centimeters (cm) Standard Deviation 1.1	4.9 centimeters (cm) Standard Deviation 1
Heart Chamber Dimensions and Wall Thicknesses LVESD (cm) at 12 Months	4.7 centimeters (cm) Standard Deviation 1.1	4.9 centimeters (cm) Standard Deviation 1
Heart Chamber Dimensions and Wall Thicknesses LVESD (cm) at 24 Months	4.8 centimeters (cm) Standard Deviation 1.1	4.8 centimeters (cm) Standard Deviation 1.1
Heart Chamber Dimensions and Wall Thicknesses LV End Diastolic Dimension(LVEDD) (cm) at Baseline	5.9 centimeters (cm) Standard Deviation 1	6 centimeters (cm) Standard Deviation 0.9
Heart Chamber Dimensions and Wall Thicknesses LVEDD (cm) at 12 Months	6 centimeters (cm) Standard Deviation 0.9	6 centimeters (cm) Standard Deviation 0.9
Heart Chamber Dimensions and Wall Thicknesses LVEDD (cm) at 24 Months	6 centimeters (cm) Standard Deviation 1	5.9 centimeters (cm) Standard Deviation 0.8
Heart Chamber Dimensions and Wall Thicknesses Septal Thickness (cm) at Baseline	1 centimeters (cm) Standard Deviation 0.3	1 centimeters (cm) Standard Deviation 0.3
Heart Chamber Dimensions and Wall Thicknesses Septal Thickness (cm) at 12 Months	1 centimeters (cm) Standard Deviation 0.3	1 centimeters (cm) Standard Deviation 0.3
Heart Chamber Dimensions and Wall Thicknesses Septal Thickness (cm) at 24 Months	1 centimeters (cm) Standard Deviation 0.3	1 centimeters (cm) Standard Deviation 0.2
Heart Chamber Dimensions and Wall Thicknesses Posterior Wall Thickness (cm) at Baseline	1 centimeters (cm) Standard Deviation 0.2	1 centimeters (cm) Standard Deviation 0.2
Heart Chamber Dimensions and Wall Thicknesses Posterior Wall Thickness (cm) at 12 Months	1 centimeters (cm) Standard Deviation 0.2	1 centimeters (cm) Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline, 12, and 24 month visits

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Echocardiogram measures for each endpoint were obtained at multiple time points.

LV Ejection Fraction is the percentage of a patient's blood moved out of the left venricle when the heart pumps. The measure is recorded as a percentage(0-100%) and the normal range is 50-85%.

LV Fractional Shortening is the percent change in a patient's LV internal dimensions between systole (when the ventricles contract and expel blood) and diastole (when the ventricles expand and receive blood). The measure is recorded as a percentage(0-100%) and the normal range is 30-45%.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Left Ventricular (LV) Ejection Fraction and Fractional Shortening LV Fractional Shortening (%) at Baseline	19.5 percentage of LV unit Standard Deviation 9.2	18.8 percentage of LV unit Standard Deviation 8.5
Left Ventricular (LV) Ejection Fraction and Fractional Shortening LV Fractional Shortening (%) at 12 Months	21.6 percentage of LV unit Standard Deviation 8.4	20.1 percentage of LV unit Standard Deviation 8.0
Left Ventricular (LV) Ejection Fraction and Fractional Shortening LV Fractional Shortening (%) at 24 Months	21.3 percentage of LV unit Standard Deviation 9.1	20.6 percentage of LV unit Standard Deviation 8.6
Left Ventricular (LV) Ejection Fraction and Fractional Shortening LV Ejection Fraction (%) at Baseline	35.3 percentage of LV unit Standard Deviation 11.9	35.5 percentage of LV unit Standard Deviation 11.6
Left Ventricular (LV) Ejection Fraction and Fractional Shortening LV Ejection Fraction (%) at 12 Months	38.8 percentage of LV unit Standard Deviation 11.9	37.3 percentage of LV unit Standard Deviation 11.8
Left Ventricular (LV) Ejection Fraction and Fractional Shortening LV Ejection Fraction (%) at 24 Months	37.6 percentage of LV unit Standard Deviation 12.5	36.7 percentage of LV unit Standard Deviation 12.0

SECONDARY outcome

Timeframe: Baseline, 12, and 24 month visits

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Echocardiogram measures for each endpoint were obtained at multiple time points.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Left Ventricular (LV) and Left Atrial (LA) Volumes LA Volume at 12 Months	74.5 milliliters (mL) Standard Deviation 28.3	73.6 milliliters (mL) Standard Deviation 27.9
Left Ventricular (LV) and Left Atrial (LA) Volumes Left Atrial (LA) Volume at Baseline	75.4 milliliters (mL) Standard Deviation 26.1	74.5 milliliters (mL) Standard Deviation 26.5
Left Ventricular (LV) and Left Atrial (LA) Volumes LA Volume at 24 Months	82.3 milliliters (mL) Standard Deviation 32.0	77.4 milliliters (mL) Standard Deviation 27.7
Left Ventricular (LV) and Left Atrial (LA) Volumes LV End Systolic Volume (LVESV) at Baseline	127.6 milliliters (mL) Standard Deviation 65.5	121.2 milliliters (mL) Standard Deviation 54.4
Left Ventricular (LV) and Left Atrial (LA) Volumes LVESV at 12 Months	108.9 milliliters (mL) Standard Deviation 59.7	105.8 milliliters (mL) Standard Deviation 53.4
Left Ventricular (LV) and Left Atrial (LA) Volumes LVESV at 24 Months	116.5 milliliters (mL) Standard Deviation 62.6	108.7 milliliters (mL) Standard Deviation 52.8
Left Ventricular (LV) and Left Atrial (LA) Volumes LV End Diastolic Volume (LVEDV) at Baseline	189.8 milliliters (mL) Standard Deviation 72.7	182.5 milliliters (mL) Standard Deviation 60.6
Left Ventricular (LV) and Left Atrial (LA) Volumes LVEDV at 12 Months	170.6 milliliters (mL) Standard Deviation 68.6	163.2 milliliters (mL) Standard Deviation 58.7
Left Ventricular (LV) and Left Atrial (LA) Volumes LVEDV at 24 Months	179.0 milliliters (mL) Standard Deviation 71.8	165.8 milliliters (mL) Standard Deviation 57.8

SECONDARY outcome

Timeframe: Baseline, 12, and 24 month visits

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Echocardiogram measures for each endpoint were obtained at multiple time points.

LV Sphericity Index is a ratio of LV long axis dimension to the LV short axis dimension. Healthy hearts have an elliptical LV cross-sectional shape. A value of 1 denotes a circular or more globular shape, while larger values denote healthier hearts with more elliptical cross sections. Literature has shown that when the ratio used is short axis/long axis, normal hearts have a median LV sphericity index of 0.56, with a range of (0.51-0.60). This translates to median=1.79,range=(1.67,1.96) for long/short axis.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Left Ventricular (LV) Sphericity Index Left Ventricular (LV) Sphericity Index at Baseline	1.5 Ratio Standard Deviation 0.2	1.5 Ratio Standard Deviation 0.2
Left Ventricular (LV) Sphericity Index LV Sphericity Index at 12 Months	1.5 Ratio Standard Deviation 0.2	1.5 Ratio Standard Deviation 0.2
Left Ventricular (LV) Sphericity Index LV Sphericity Index at 24 Months	1.6 Ratio Standard Deviation 0.2	1.5 Ratio Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline, 12, and 24 month visits

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Echocardiogram measures for each endpoint were obtained at multiple time points.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Hemodynamic Velocity Measures Tricuspid Regurgitation (TR) Velocity at Baseline	2.7 meters per second (m/s) Standard Deviation 0.4	2.7 meters per second (m/s) Standard Deviation 0.5
Hemodynamic Velocity Measures TR Velocity at 12 Months	2.7 meters per second (m/s) Standard Deviation 0.4	2.7 meters per second (m/s) Standard Deviation 0.4
Hemodynamic Velocity Measures TR Velocity at 24 Months	2.7 meters per second (m/s) Standard Deviation 0.4	2.6 meters per second (m/s) Standard Deviation 0.5
Hemodynamic Velocity Measures Mitral Inflow - peak E at Baseline	0.8 meters per second (m/s) Standard Deviation 0.2	0.8 meters per second (m/s) Standard Deviation 0.3
Hemodynamic Velocity Measures Mitral Inflow - peak E at 12 Months	0.7 meters per second (m/s) Standard Deviation 0.3	0.7 meters per second (m/s) Standard Deviation 0.3
Hemodynamic Velocity Measures Mitral Inflow - peak E at 24 Months	0.7 meters per second (m/s) Standard Deviation 0.3	0.7 meters per second (m/s) Standard Deviation 0.3
Hemodynamic Velocity Measures Mitral Inflow - peak A at Baseline	0.7 meters per second (m/s) Standard Deviation 0.3	0.7 meters per second (m/s) Standard Deviation 0.3
Hemodynamic Velocity Measures Mitral Inflow - peak A at 12 Months	0.7 meters per second (m/s) Standard Deviation 0.2	0.8 meters per second (m/s) Standard Deviation 0.2
Hemodynamic Velocity Measures Mitral Inflow - peak A at 24 Months	0.7 meters per second (m/s) Standard Deviation 0.2	0.8 meters per second (m/s) Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline, 12, and 24 month visits

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Echocardiogram measures for each endpoint were obtained at multiple time points.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Hemodynamic Deceleration Time Mitral Inflow - Deceleration Time at Baseline	194.6 milliseconds (ms) Standard Deviation 50.6	192.3 milliseconds (ms) Standard Deviation 50.6
Hemodynamic Deceleration Time Mitral Inflow - Deceleration Time at 12 Months	206.8 milliseconds (ms) Standard Deviation 54.7	208.7 milliseconds (ms) Standard Deviation 61.0
Hemodynamic Deceleration Time Mitral Inflow - Deceleration Time at 24 Months	208.0 milliseconds (ms) Standard Deviation 54.6	210.7 milliseconds (ms) Standard Deviation 56.9

SECONDARY outcome

Timeframe: Baseline, 12, and 24 month visits

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Echocardiogram measures for each endpoint were obtained at multiple time points.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Left Atrial (LA) and Mitral Regurgitation (MR) Areas Left Atrial (LA) Area at Baseline	22.7 centimeters squared (cm2) Standard Deviation 5.8	22.5 centimeters squared (cm2) Standard Deviation 5.9
Left Atrial (LA) and Mitral Regurgitation (MR) Areas LA Area at 12 Months	22.0 centimeters squared (cm2) Standard Deviation 5.5	21.9 centimeters squared (cm2) Standard Deviation 6.4
Left Atrial (LA) and Mitral Regurgitation (MR) Areas LA Area at 24 Months	22.0 centimeters squared (cm2) Standard Deviation 6.0	21.9 centimeters squared (cm2) Standard Deviation 6.3
Left Atrial (LA) and Mitral Regurgitation (MR) Areas Mitral Regurgitation (MR) Area at Baseline	4.8 centimeters squared (cm2) Standard Deviation 4.3	5.1 centimeters squared (cm2) Standard Deviation 4.7
Left Atrial (LA) and Mitral Regurgitation (MR) Areas MR Area at 12 Months	4.8 centimeters squared (cm2) Standard Deviation 4.9	4.5 centimeters squared (cm2) Standard Deviation 4.3
Left Atrial (LA) and Mitral Regurgitation (MR) Areas MR Area at 24 Months	5.0 centimeters squared (cm2) Standard Deviation 4.5	4.7 centimeters squared (cm2) Standard Deviation 4.0

SECONDARY outcome

Timeframe: Baseline, 12, and 24 month visits

Echocardiogram measures for this endpoint were obtained at multiple time points. Composite MR Severity was measured on a scale of "None to Trivial" to "Grade IV", with Grade IV being the worst possible score and "None to Trivial" being the best possible score.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Composite Mitral Regurgitation (MR) Severity Score Baseline MR Score of None to Trivial	236 participants	232 participants
Composite Mitral Regurgitation (MR) Severity Score Baseline MR Score: Grade I	160 participants	148 participants
Composite Mitral Regurgitation (MR) Severity Score Baseline MR Score: Grade II	48 participants	63 participants
Composite Mitral Regurgitation (MR) Severity Score Baseline MR Score: Grade III	18 participants	14 participants
Composite Mitral Regurgitation (MR) Severity Score Baseline MR Score: Grade IV	10 participants	14 participants
Composite Mitral Regurgitation (MR) Severity Score Baseline MR Score: Indeterminate	9 participants	22 participants
Composite Mitral Regurgitation (MR) Severity Score 12 Month MR Score: None to Trivial	198 participants	201 participants
Composite Mitral Regurgitation (MR) Severity Score 12 Month MR Score: Grade I	133 participants	119 participants
Composite Mitral Regurgitation (MR) Severity Score 12 Month MR Score: Grade II	46 participants	42 participants
Composite Mitral Regurgitation (MR) Severity Score 12 Month MR Score: Grade III	17 participants	13 participants
Composite Mitral Regurgitation (MR) Severity Score 12 Month MR Score: Grade IV	6 participants	4 participants
Composite Mitral Regurgitation (MR) Severity Score 12 Month Score: Indeterminate	8 participants	14 participants
Composite Mitral Regurgitation (MR) Severity Score 24 Month MR Score: None to Trivial	174 participants	164 participants
Composite Mitral Regurgitation (MR) Severity Score 24 Month MR Score: Grade I	130 participants	118 participants
Composite Mitral Regurgitation (MR) Severity Score 24 Month MR Score: Grade II	30 participants	27 participants
Composite Mitral Regurgitation (MR) Severity Score 24 Month MR Score: Grade III	8 participants	11 participants
Composite Mitral Regurgitation (MR) Severity Score 24 Month MR Score: Grade IV	9 participants	6 participants
Composite Mitral Regurgitation (MR) Severity Score 24 Month Score: Indeterminate	6 participants	9 participants

SECONDARY outcome

Timeframe: Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Occurrence of Ventricular Tachycardia ("VT") and Ventricular Fibrillation ("VF") Episodes True VT/VF	0.170 Annualized Episodes per Patient Month	0.155 Annualized Episodes per Patient Month
Occurrence of Ventricular Tachycardia ("VT") and Ventricular Fibrillation ("VF") Episodes Inappropriately detected non-VT/VF	0.038 Annualized Episodes per Patient Month	0.055 Annualized Episodes per Patient Month

SECONDARY outcome

Timeframe: Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic AF, which was an exclusion criterion. Of the remaining 1030 randomized subjects that met all inclusion criteria, only those with no history of AF were included in the analysis (445 in the VVI 40 arm and 444 in the MVP arm). An intention to treat analysis was performed.

Persistent AF was defined as any of the following:

1. 2 consecutive visits in which the patient presents with AF

2. 7 consecutive days of at least 22 hours per day of AT/AF

3. A cardioversion prior to 7 consecutive days of at least 22 hours per day of AT/AF

Clinically Important AF was defined as more than 20 hours of AT/AF in a single day

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History	445 participants	444 participants

SECONDARY outcome

Timeframe: Enrollment to last visit (up to 45 months post-randomization)

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Physician identification of a Class I Pacing Indication. A Class I Pacing Indication implies that the benefit of pacing the heart far exceeds the risk, and that the procedure to implant the pacing device should be performed. For this indication there is general agreement that pacing the heart is beneficial, useful, and effective.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Development of a Pacing Indication During the Study	38 participants	19 participants

SECONDARY outcome

Timeframe: Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Whether a subject is on each of a pre-specified set of drugs or classes of drugs.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month Amiodarone	12.5 Percentage of Subjects	13.1 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month Amiodarone	12.7 Percentage of Subjects	14.8 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month Amiodarone	13.5 Percentage of Subjects	12.1 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline Amiodarone	12.7 Percentage of Subjects	11.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month Amiodarone	12.2 Percentage of Subjects	12.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month Amiodarone	8.0 Percentage of Subjects	12.3 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline Sotalol	1.0 Percentage of Subjects	0.8 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month Sotalol	1.4 Percentage of Subjects	1.6 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month Sotalol	2.0 Percentage of Subjects	1.0 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month Sotalol	2.7 Percentage of Subjects	1.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month Sotalol	3.6 Percentage of Subjects	3.0 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month Sotalol	5.3 Percentage of Subjects	1.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline Beta Blockers	88.7 Percentage of Subjects	88.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month Beta Blockers	91.1 Percentage of Subjects	90.6 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month Beta Blockers	92.3 Percentage of Subjects	90.3 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month Beta Blockers	92.6 Percentage of Subjects	90.2 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month Beta Blockers	91.0 Percentage of Subjects	92.9 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month Beta Blockers	89.3 Percentage of Subjects	87.7 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline Amlodipine	5.5 Percentage of Subjects	6.6 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month Amlodipine	4.9 Percentage of Subjects	7.3 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month Amlodipine	5.7 Percentage of Subjects	7.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month Amlodipine	6.6 Percentage of Subjects	8.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month Amlodipine	7.2 Percentage of Subjects	9.1 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month Amlodipine	6.7 Percentage of Subjects	13.7 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline Diltiazem	1.8 Percentage of Subjects	0.6 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month Diltiazem	1.9 Percentage of Subjects	0.7 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month Diltiazem	1.8 Percentage of Subjects	0.7 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month Diltiazem	1.9 Percentage of Subjects	0.6 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month Diltiazem	1.8 Percentage of Subjects	0 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month Diltiazem	2.7 Percentage of Subjects	1.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline Verapamil	0.8 Percentage of Subjects	0.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month Verapamil	1.2 Percentage of Subjects	0.5 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month Verapamil	0.7 Percentage of Subjects	0.5 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month Verapamil	1.6 Percentage of Subjects	0.3 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month Verapamil	0 Percentage of Subjects	0 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month Verapamil	4.0 Percentage of Subjects	0 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline ACE-Inhibitors	66.7 Percentage of Subjects	68.9 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month ACE-Inhibitors	64.9 Percentage of Subjects	70.7 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month ACE-Inhibitors	67.6 Percentage of Subjects	70.8 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month ACE-Inhibitors	67.6 Percentage of Subjects	70.7 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month ACE-Inhibitors	73.0 Percentage of Subjects	74.7 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month ACE-Inhibitors	70.7 Percentage of Subjects	64.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline ARBs	18.1 Percentage of Subjects	15.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month ARBs	20.7 Percentage of Subjects	16.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month ARBs	20.9 Percentage of Subjects	17.3 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month ARBs	21.8 Percentage of Subjects	17.9 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month ARBs	19.8 Percentage of Subjects	17.2 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month ARBs	20.0 Percentage of Subjects	26.0 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline Aldosterone Receptor Antagonists	17.9 Percentage of Subjects	19.1 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month Aldosterone Receptor Antagonists	17.6 Percentage of Subjects	21.3 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month Aldosterone Receptor Antagonists	17.9 Percentage of Subjects	21.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month Aldosterone Receptor Antagonists	16.4 Percentage of Subjects	21.5 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month Aldosterone Receptor Antagonists	17.1 Percentage of Subjects	24.2 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month Aldosterone Receptor Antagonists	13.3 Percentage of Subjects	17.8 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline Spironolactone	13.8 Percentage of Subjects	13.3 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month Spironolactone	13.2 Percentage of Subjects	15.2 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month Spironolactone	13.4 Percentage of Subjects	14.3 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month Spironolactone	13.3 Percentage of Subjects	15.1 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month Spironolactone	16.2 Percentage of Subjects	17.2 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month Spironolactone	10.7 Percentage of Subjects	12.3 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline Diuretics	54.2 Percentage of Subjects	53.9 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month Diuretics	58.6 Percentage of Subjects	56.4 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month Diuretics	58.0 Percentage of Subjects	57.2 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month Diuretics	58.6 Percentage of Subjects	58.1 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month Diuretics	56.8 Percentage of Subjects	56.6 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month Diuretics	56.0 Percentage of Subjects	60.3 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction Baseline Digoxin	21.6 Percentage of Subjects	18.7 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 6 Month Digoxin	21.6 Percentage of Subjects	17.8 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 12 Month Digoxin	21.5 Percentage of Subjects	18.5 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 24 Month Digoxin	20.4 Percentage of Subjects	17.9 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 30 Month Digoxin	22.5 Percentage of Subjects	19.2 Percentage of Subjects
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction 36 Month Digoxin	17.3 Percentage of Subjects	8.2 Percentage of Subjects

SECONDARY outcome

Timeframe: Enrollment, 6, 12, 24 and 36 month visits

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

The percentage of a patients' ventricular beats that were paced by the device.

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Percent Ventricular Pacing Baseline to 6 Months	0.7 Percent pacing Standard Deviation 3.7	0.8 Percent pacing Standard Deviation 3.4
Percent Ventricular Pacing Baseline to 12 Months	1.1 Percent pacing Standard Deviation 5.5	1.0 Percent pacing Standard Deviation 4.0
Percent Ventricular Pacing Baseline to 24 Months	1.8 Percent pacing Standard Deviation 8.0	1.6 Percent pacing Standard Deviation 6.4
Percent Ventricular Pacing Baseline to 36 Months	3.4 Percent pacing Standard Deviation 13.8	1.5 Percent pacing Standard Deviation 6.9

SECONDARY outcome

Timeframe: Baseline, 12, 24, and 36 month visits

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Minnesota Living with Heart Failure Questionnaire ("MLWHFQ") and Kansas City Cardiomyopathy Questionnaire ("KCCQ") Quality of Life("QOL") Scores. For KCCQ, positive values mean improved QOL compared to baseline. For MLWHFQ, negative values mean improved QOL compared to baseline.

Scales: KCCQ 0-100 (0=worst, 100 best); MLWHFQ 0-105 (105=worst, 0=best)

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
Quality of Life ("QOL") Score KCCQ Physical Limitation(12 Mo. -Baseline Change)	0.3 Units on a scale Standard Deviation 25.8	4.1 Units on a scale Standard Deviation 28.5
Quality of Life ("QOL") Score KCCQ Physical Limitation(24 Mo. -Baseline Change)	-2.2 Units on a scale Standard Deviation 28.5	-0.1 Units on a scale Standard Deviation 31.4
Quality of Life ("QOL") Score KCCQ Physical Limitation(36 Mo. -Baseline Change)	-11.0 Units on a scale Standard Deviation 32.5	-11.0 Units on a scale Standard Deviation 30.8
Quality of Life ("QOL") Score KCCQ Clinical Summary(24 Mo.-Baseline Change)	0.2 Units on a scale Standard Deviation 28.1	1.2 Units on a scale Standard Deviation 29.3
Quality of Life ("QOL") Score KCCQ Symptom Stability(12 Mo. -Baseline Change)	1.8 Units on a scale Standard Deviation 28.5	3.1 Units on a scale Standard Deviation 27.1
Quality of Life ("QOL") Score KCCQ Symptom Stability(24 Mo. -Baseline Change)	-1.5 Units on a scale Standard Deviation 28.5	-0.6 Units on a scale Standard Deviation 30.7
Quality of Life ("QOL") Score KCCQ Symptom Stability(36 Mo. -Baseline Change)	-10.8 Units on a scale Standard Deviation 29.0	-10.5 Units on a scale Standard Deviation 33.6
Quality of Life ("QOL") Score KCCQ Symptom Frequency(12 Mo. -Baseline Change)	4.7 Units on a scale Standard Deviation 27.8	5.1 Units on a scale Standard Deviation 27.4
Quality of Life ("QOL") Score KCCQ Symptom Frequency(24 Mo. -Baseline Change)	2.2 Units on a scale Standard Deviation 31.9	1.7 Units on a scale Standard Deviation 31.8
Quality of Life ("QOL") Score KCCQ Symptom Frequency(36 Mo. -Baseline Change)	-7.1 Units on a scale Standard Deviation 37.4	-10.1 Units on a scale Standard Deviation 33.1
Quality of Life ("QOL") Score KCCQ Symptom Burden(12 Mo. -Baseline Change)	4.8 Units on a scale Standard Deviation 27.7	5.9 Units on a scale Standard Deviation 28.6
Quality of Life ("QOL") Score KCCQ Symptom Burden(24 Mo. -Baseline Change)	2.4 Units on a scale Standard Deviation 32.3	3.2 Units on a scale Standard Deviation 33.0
Quality of Life ("QOL") Score KCCQ Symptom Burden(36 Mo. -Baseline Change)	-7.3 Units on a scale Standard Deviation 38.2	-8.6 Units on a scale Standard Deviation 34.3
Quality of Life ("QOL") Score KCCQ Total Symptoms(12 Mo. -Baseline Change)	4.7 Units on a scale Standard Deviation 26.7	5.5 Units on a scale Standard Deviation 26.9
Quality of Life ("QOL") Score KCCQ Total Symptoms(24 Mo. -Baseline Change)	2.3 Units on a scale Standard Deviation 31.2	2.4 Units on a scale Standard Deviation 31.4
Quality of Life ("QOL") Score KCCQ Total Symptoms(36 Mo. -Baseline Change)	-7.2 Units on a scale Standard Deviation 36.9	-9.3 Units on a scale Standard Deviation 33
Quality of Life ("QOL") Score KCCQ Self-Efficacy(12 Mo. -Baseline Change)	1.9 Units on a scale Standard Deviation 28.9	4.9 Units on a scale Standard Deviation 30.5
Quality of Life ("QOL") Score KCCQ Self-Efficacy(24 Mo. -Baseline Change)	-0.9 Units on a scale Standard Deviation 34.1	-0.2 Units on a scale Standard Deviation 35.9
Quality of Life ("QOL") Score KCCQ Self-Efficacy(36 Mo. -Baseline Change)	-12.6 Units on a scale Standard Deviation 43.2	-12.5 Units on a scale Standard Deviation 43.5
Quality of Life ("QOL") Score KCCQ Quality of Life(12 Mo. -Baseline Change)	12.9 Units on a scale Standard Deviation 31.8	16.6 Units on a scale Standard Deviation 32.1
Quality of Life ("QOL") Score KCCQ Quality of Life(24 Mo. -Baseline Change)	11.3 Units on a scale Standard Deviation 35.7	14.6 Units on a scale Standard Deviation 35.5
Quality of Life ("QOL") Score KCCQ Quality of Life(36 Mo. -Baseline Change)	0.7 Units on a scale Standard Deviation 39.4	0.9 Units on a scale Standard Deviation 33.1
Quality of Life ("QOL") Score KCCQ Social Limitation(12 Mo.-Baseline Change)	5.6 Units on a scale Standard Deviation 31.7	8.1 Units on a scale Standard Deviation 33.5
Quality of Life ("QOL") Score KCCQ Social Limitation(24 Mo.-Baseline Change)	3.4 Units on a scale Standard Deviation 35.9	6.1 Units on a scale Standard Deviation 36.4
Quality of Life ("QOL") Score KCCQ Clinical Summary(12 Mo.-Baseline Change)	2.8 Units on a scale Standard Deviation 24.1	4.9 Units on a scale Standard Deviation 25.9
Quality of Life ("QOL") Score KCCQ Social Limitation(36 Mo.-Baseline Change)	-6.4 Units on a scale Standard Deviation 40.7	-2.3 Units on a scale Standard Deviation 32.2
Quality of Life ("QOL") Score KCCQ Overall Summary(12 Mo.-Baseline Change)	6.1 Units on a scale Standard Deviation 25.1	8.7 Units on a scale Standard Deviation 26.7
Quality of Life ("QOL") Score KCCQ Overall Summary(24 Mo.-Baseline Change)	3.7 Units on a scale Standard Deviation 29.4	5.7 Units on a scale Standard Deviation 30.2
Quality of Life ("QOL") Score KCCQ Overall Summary(36 Mo.-Baseline Change)	-5.1 Units on a scale Standard Deviation 34.7	-5.4 Units on a scale Standard Deviation 28.7
Quality of Life ("QOL") Score KCCQ Clinical Summary(36 Mo.-Baseline Change)	-8.4 Units on a scale Standard Deviation 33.8	-9.7 Units on a scale Standard Deviation 29.6
Quality of Life ("QOL") Score MLWHFQ (12 Month - Baseline Change)	-5.8 Units on a scale Standard Deviation 24.6	-7.9 Units on a scale Standard Deviation 28.5
Quality of Life ("QOL") Score MLWHFQ (24 Month - Baseline Change)	-2 Units on a scale Standard Deviation 30.6	-4 Units on a scale Standard Deviation 31.7
Quality of Life ("QOL") Score MLWHFQ (36 Month - Baseline Change)	8.4 Units on a scale Standard Deviation 37	5.9 Units on a scale Standard Deviation 32.1

SECONDARY outcome

Timeframe: Enrollment to last visit (up to 45 months post-randomization) or death

Population: 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective.

Death from any cause

Outcome measures

Measure	VVI 40 n=512 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 Participants Managed Ventricular Pacing at a rate of 60 beats per minute
All Cause Mortality	46 participants who died	57 participants who died

SECONDARY outcome

Timeframe: Period of time prior to patient consent when considering patient for Implant/Enrollment

Population: Centers kept a screening log, recording for each patient considered for new ICD implant and possible trial enrollment whether the patient had a Class I pacing indication at time of implant. The analysis consisted of descriptive statistics (counts of the 2051 screened patients).

Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant

Outcome measures

Measure	VVI 40 n=2051 Participants Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing Managed Ventricular Pacing at a rate of 60 beats per minute
ICD-indicated Patients With Class I Pacemaker Indication. Class I Pacing Indication at Implant	220 participants 0.68	—
ICD-indicated Patients With Class I Pacemaker Indication. No Class I Pacing Indication at Implant	1818 participants 0.70	—
ICD-indicated Patients With Class I Pacemaker Indication. Class I Pacing Indication Status Not Recorded	13 participants 2.20	—

Adverse Events

VVI 40 Pacing

Serious events: 128 serious events

Other events: 116 other events

Deaths: 0 deaths

MVP Pacing

Serious events: 121 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Measure	VVI 40 Pacing n=513 participants at risk Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 participants at risk Managed Ventricular Pacing at a rate of 60 beats per minute
Renal and urinary disorders Acute Renal Insufficiency	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Blood and lymphatic system disorders Anemia	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.58% 3/518 • Number of events 3 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Atrial Fibrillation	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Atrial Flutter	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Cardiac Arrest	1.2% 6/513 • Number of events 6 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	1.5% 8/518 • Number of events 8 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Cardiogenic Shock	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Cerebellar Hematoma	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Cerebral Hemorrhage	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disorder	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Chronic Obstructive Pulmonary Disorder with Renal Failure	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Injury, poisoning and procedural complications Closed Head Trauma	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Congestive Heart Failure	9.7% 50/513 • Number of events 91 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	10.2% 53/518 • Number of events 88 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Acute Respiratory Distress Syndrome	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Anemia	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Congestive Heart Failure with Angina	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Congestive Heart Failure with Atrial Fibrillation	0.39% 2/513 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.77% 4/518 • Number of events 4 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Congestive Heart Failure with Atrial Flutter	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Bronchitis	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Cellulitis and Anemia	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Chronic Obstructive Pulmonary Disease	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Coronary Artery Disease	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Coronary Artery Disease and Atrial Fibrillation	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Coronary Artery Disease, SVT and VT	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Infection - Respiratory Tract	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Congestive Heart Failure with Myocardial Infarction	0.39% 2/513 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Myocardial Infarction and Renal Failure	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Pneumonia	0.39% 2/513 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Pneumonia and Renal Failure	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Pneumothorax and Right Atrial Lead Dislodgement	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Renal Failure	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Congestive Heart Failure with Stroke	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Congestive Heart Failure with Ventricular Fibrillation	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Congestive Heart Failure with Ventricular Tachycardia	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Vascular disorders Coronary Artery Disease	0.58% 3/513 • Number of events 3 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Coronary Artery Disease with Ventricular Tachycardia	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Vascular disorders Deep Vein Thrombosis	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Dehydration	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Gastrointestinal disorders Gastrointestinal Bleed	0.58% 3/513 • Number of events 3 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Hyperkalemia	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Hypokalemia	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Hypotension	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Increased Right Ventricular Lead Impedance	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Infections and infestations Infection	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Infections and infestations Infection - Device, Leads	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.77% 4/518 • Number of events 4 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Infections and infestations Infection - Incision Site	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Infections and infestations Infection - Pocket	0.39% 2/513 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.58% 3/518 • Number of events 3 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Infections and infestations Infection - Systemic	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.58% 3/518 • Number of events 3 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Infections and infestations Infection - Urinary Tract	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Lead Dislodgement - Right Ventricular Lead	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Lead Fracture - Right Ventricular Lead	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.58% 3/518 • Number of events 3 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Lead Perforation - Right Ventricular Lead	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Lead Protrusion - Right Ventricular Lead	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia - Myelogenous	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Medication Allergy	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Metabolism and nutrition disorders Metabolic Acidosis	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Myocardial Infarction	3.1% 16/513 • Number of events 17 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	2.3% 12/518 • Number of events 13 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Myocardial Infarction with Atrial Fibrillation	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Skin and subcutaneous tissue disorders Necrosis - Left Lower Extremity	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Blood and lymphatic system disorders Pantocytopenia	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Pericardial Effusion	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Vascular disorders Peripheral Vascular Disease	0.39% 2/513 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Pleural Effusion with Renal Failure and Sepsis	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Pneumonia	0.78% 4/513 • Number of events 4 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Pneumonia with Myocardial Infarction	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.58% 3/513 • Number of events 3 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.77% 4/518 • Number of events 4 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Premature Battery Depletion	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Pulmonary Embolus	0.78% 4/513 • Number of events 4 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Renal and urinary disorders Renal Failure	1.2% 6/513 • Number of events 6 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.58% 3/518 • Number of events 4 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Respiratory Failure with Pneumonia and Atrial Fibrillation	0.00% 0/513 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.19% 1/518 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Sepsis	0.58% 3/513 • Number of events 5 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.58% 3/518 • Number of events 3 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Respiratory, thoracic and mediastinal disorders Sleep Apnea	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Stroke	2.1% 11/513 • Number of events 12 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.97% 5/518 • Number of events 5 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
General disorders Subdural Hematoma	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.00% 0/518 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Ventricular Tachycardia	2.1% 11/513 • Number of events 11 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	1.4% 7/518 • Number of events 8 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Ventricular Tachycardia and Ventricular Fibrillation	0.19% 1/513 • Number of events 1 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	0.39% 2/518 • Number of events 2 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.

Other adverse events

Measure	VVI 40 Pacing n=513 participants at risk Backup ventricular pacing at a rate of 40 beats per minute	MVP Pacing n=518 participants at risk Managed Ventricular Pacing at a rate of 60 beats per minute
Cardiac disorders Chest Pain	7.0% 36/513 • Number of events 42 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	8.3% 43/518 • Number of events 51 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Congestive Heart Failure	10.7% 55/513 • Number of events 73 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	8.5% 44/518 • Number of events 59 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Cardiac disorders Ventricular Tachycardia	4.9% 25/513 • Number of events 30 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.	5.0% 26/518 • Number of events 32 • From enrollment to study exit or closure (up to 45 months post-randomization) Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.

Additional Information

MVP Clinical Trial Leader

Medtronic, Inc.

Email: medtroniccrmtrials@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigational Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication.
• Publication restrictions are in place

Restriction type: OTHER