Managed Ventricular Pacing (MVP) Trial

MVP Trial (Managed Ventricular Pacing (MVP) Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute (VVI 40) Pacing Trial)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00281099

Acronym

MVP

Enrollment

1031

Registered

2006-01-24

Start date

2004-10-31

Completion date

2008-07-31

Last updated

2010-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease

Keywords

ICD, Pacing, Heart Failure

Brief summary

The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator (ICD) can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). The study will compare how much time either ICD wire is used by the ICD and the status of congestive heart failure.

Detailed description

Recent research supports the hypothesis that reducing the amount of pacing in the lower right chamber of the heart may prevent the progression of congestive heart failure (CHF) in some implantable cardioverter defibrillator (ICD) patients. CHF refers to symptoms (shortness of breath, fatigue, fluid overload) caused by decreased pumping action of the heart muscle. The ICD can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). Both settings allow the heart to beat more naturally using its own electrical signals. Two device settings will be compared. Managed ventricular pacing (MVP) will allow the ICD to use both wires only as necessary. This setting allows the ICD to send electrical signals to the top and bottom chambers of the heart if needed. The other setting, ventricular pacing (VVI) will allow the ICD to operate the bottom chamber of the heart if it is needed.

Interventions

DEVICEICD (Implantable Cardioverter Defibrillator)

VVI 40 vs. MVP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Conventional indication for ICD therapy according to current evidence-based guidelines and in accordance with the corresponding United States Centers for Medicare and Medicaid Services National Coverage Determination for the use of ICDs. * Prior myocardial infarction (MI) and an left ventricular ejection fraction (LVEF) of less than 30% * Ischemic Dilated Cardiomyopathy (IDCM), New York Heart Association (NYHA) Class II or II heart failure, and LVEF less than or equal to 35% * Non-Ischemic Dilated Cardiomyopathy (NIDCM) greater than 3 months, NYHA Class II or II heart failure, and LVEF less than or equal to 35% * First ICD implant * Successful implant with a study device with approved labeling

Exclusion criteria

* Failure to meet any of the inclusion criteria * Class I pacing indication * Chronic atrial fibrillation (AF) without any documented sinus mechanism for at least 6 months * Inability or unwillingness to give informed consent * Life expectancy less than 12 months or a heart transplant anticipated within 6 months * Inability to successfully comply with study participation and follow up requirements * Patient involved in another clinical trial that may confound the results of the study

Design outcomes

Primary

Measure	Time frame	Description
All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure (HF) Hospitalizations.	Enrollment to last visit (up to 45 months post-randomization) or death	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)

Secondary

Measure	Time frame	Description
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline, 12, 24 and 36 month visits	NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst.
Heart Chamber Dimensions and Wall Thicknesses	Baseline, 12, and 24 month visits	Echocardiogram measures for each endpoint were obtained at multiple time points.
Left Ventricular (LV) Ejection Fraction and Fractional Shortening	Baseline, 12, and 24 month visits	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%.
Left Ventricular (LV) and Left Atrial (LA) Volumes	Baseline, 12, and 24 month visits	Echocardiogram measures for each endpoint were obtained at multiple time points.
Left Ventricular (LV) Sphericity Index	Baseline, 12, and 24 month visits	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.
Hemodynamic Velocity Measures	Baseline, 12, and 24 month visits	Echocardiogram measures for each endpoint were obtained at multiple time points.
Hemodynamic Deceleration Time	Baseline, 12, and 24 month visits	Echocardiogram measures for each endpoint were obtained at multiple time points.
Left Atrial (LA) and Mitral Regurgitation (MR) Areas	Baseline, 12, and 24 month visits	Echocardiogram measures for each endpoint were obtained at multiple time points.
Occurrence of Worsening Heart Failure-related Adverse Events	Enrollment to last visit (up to 45 months post-randomization)	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
Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes	Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)	Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF
Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History	Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)	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
Development of a Pacing Indication During the Study	Enrollment to last visit (up to 45 months post-randomization)	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.
Medication Usage Affecting Heart Rate and Atrioventricular (AV) Conduction	Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months	Whether a subject is on each of a pre-specified set of drugs or classes of drugs.
Percent Ventricular Pacing	Enrollment, 6, 12, 24 and 36 month visits	The percentage of a patients' ventricular beats that were paced by the device.
Quality of Life (QOL) Score	Baseline, 12, 24, and 36 month visits	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)
All Cause Mortality	Enrollment to last visit (up to 45 months post-randomization) or death	Death from any cause
ICD-indicated Patients With Class I Pacemaker Indication.	Period of time prior to patient consent when considering patient for Implant/Enrollment	Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant
Composite Mitral Regurgitation (MR) Severity Score	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.

Countries

Austria, Canada, Denmark, France, Germany, Israel, Italy, Norway, Spain, Switzerland, United Kingdom, United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
VVI 40 Pacing Backup ventricular pacing at a rate of 40 beats per minute	513
MVP Pacing Managed Ventricular Pacing at a rate of 60 beats per minute	518
Total	1,031

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	46	57
Overall Study	Heart Transplant/Device Exit/Changeout	5	4
Overall Study	Lost to Follow-up	10	19
Overall Study	Physician Decision	79	72
Overall Study	Withdrawal by Subject	65	70

Baseline characteristics

Characteristic	VVI 40 Pacing	Total	MVP Pacing
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	224 Participants	458 Participants	234 Participants
Age, Categorical Between 18 and 65 years	289 Participants	573 Participants	284 Participants
Age Continuous	61.7 years STANDARD_DEVIATION 11.7	62.2 years STANDARD_DEVIATION 11.9	62.6 years STANDARD_DEVIATION 12
Region of Enrollment Austria	1 participants	1 participants	0 participants
Region of Enrollment Canada	58 participants	118 participants	60 participants
Region of Enrollment Denmark	4 participants	7 participants	3 participants
Region of Enrollment France	3 participants	6 participants	3 participants
Region of Enrollment Germany	14 participants	30 participants	16 participants
Region of Enrollment Israel	14 participants	29 participants	15 participants
Region of Enrollment Italy	11 participants	23 participants	12 participants
Region of Enrollment Spain	2 participants	5 participants	3 participants
Region of Enrollment Switzerland	9 participants	18 participants	9 participants
Region of Enrollment United Kingdom	7 participants	14 participants	7 participants
Region of Enrollment United States	390 participants	780 participants	390 participants
Sex: Female, Male Female	108 Participants	212 Participants	104 Participants
Sex: Female, Male Male	405 Participants	819 Participants	414 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	116 / 513	113 / 518
serious Total, serious adverse events	128 / 513	121 / 518

Outcome results

Primary

All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure (HF) Hospitalizations.

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)

Time frame: 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.

Arm	Measure	Value (NUMBER)
VVI 40	All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure (HF) Hospitalizations.	167 events
MVP Pacing	All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure (HF) Hospitalizations.	188 events

Comparison: This is a multiple events survival analysis, with time to first primary endpoint, time between successive endpoints, and time from last endpoint to last follow-up visit determined for each subject. The null hypothesis is that the mortality/ heart failure (HF) urgent care/HF hospitalization hazard rate for patients with no Class I pacing indication and MVP is greater than that of similar patients with VVI 40.96.3% CI: [1.139, 1.59]Andersen-Gill Model

Secondary

All Cause Mortality

Death from any cause

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

Arm	Measure	Value (NUMBER)
VVI 40	All Cause Mortality	46 participants who died
MVP Pacing	All Cause Mortality	57 participants who died

Comparison: The time from randomization to all cause mortality or last follow-up visit was determined for each subject. The null hypothesis was that the mortality hazard rate for patients with MVP programming was greater than that of patients with VVI40 programming.95% CI: [1.26, 1.75]

Secondary

Composite Mitral Regurgitation (MR) Severity Score

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.

Time frame: Baseline, 12, and 24 month visits

Arm	Measure	Group	Value (NUMBER)
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	12 Month MR Score: Grade III	17 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score of None to Trivial	236 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	12 Month MR Score: Grade IV	6 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score: Indeterminate	9 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	12 Month Score: Indeterminate	8 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score: Grade II	48 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	24 Month MR Score: None to Trivial	174 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	12 Month MR Score: None to Trivial	198 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	24 Month MR Score: Grade I	130 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score: Grade III	18 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	24 Month MR Score: Grade II	30 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	12 Month MR Score: Grade I	133 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	24 Month MR Score: Grade III	8 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score: Grade I	160 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	24 Month MR Score: Grade IV	9 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	12 Month MR Score: Grade II	46 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	24 Month Score: Indeterminate	6 participants
VVI 40	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score: Grade IV	10 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	24 Month Score: Indeterminate	9 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score: Grade II	63 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score: Grade I	148 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score: Grade III	14 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score: Grade IV	14 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score: Indeterminate	22 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	12 Month MR Score: None to Trivial	201 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	12 Month MR Score: Grade I	119 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	12 Month MR Score: Grade II	42 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	12 Month MR Score: Grade III	13 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	12 Month MR Score: Grade IV	4 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	12 Month Score: Indeterminate	14 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	24 Month MR Score: None to Trivial	164 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	24 Month MR Score: Grade I	118 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	24 Month MR Score: Grade II	27 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	24 Month MR Score: Grade III	11 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	24 Month MR Score: Grade IV	6 participants
MVP Pacing	Composite Mitral Regurgitation (MR) Severity Score	Baseline MR Score of None to Trivial	232 participants

Comparison: A General Estimating Equation (GEE) Cumulative Logits model was fit with Arm, Time, and their interaction as covariates in the model to test the hypothesis that patients with no pacing indication and MVP programming have different Mitral Regurgation over time than similar patients with VVI 40 programming. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.p-value: 0.8403Cumulative Logits Model

Secondary

Development of a Pacing Indication During the Study

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.

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

Arm	Measure	Value (NUMBER)
VVI 40	Development of a Pacing Indication During the Study	38 participants
MVP Pacing	Development of a Pacing Indication During the Study	19 participants

Comparison: Physicians recorded at each scheduled and unscheduled follow-up whether the subject had developed a Class I indication since their last visit. The time from randomization to Class I indication development or last visit if censored was determined for each subject. The null hypothesis was that the hazard rate for time to development of a Class I pacing indication among patients with MVP programming was equal to or greater than that of patients with VVI 40 programming.p-value: 0.0053Log Rank

Secondary

Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time

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

Time frame: Baseline, 12, 24 and 36 month visits

Arm	Measure	Group	Value (NUMBER)
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline NYHA I	140 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline NYHA II	271 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline NYHA III	93 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline NYHA IV	1 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline NYHA Obtained Outside Window	7 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA I	139 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA II	242 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA III	46 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA IV	5 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA Missing due to Death	21 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA Missing For Other Reasons	59 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA I	119 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA II	205 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA III	44 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA IV	2 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA Missing due to Death	39 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA Missing For Other Reasons	103 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA I	18 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA II	46 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA III	8 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA IV	1 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA Missing due to Death	46 participants
VVI 40	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA Missing For Other Reasons	393 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA I	104 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline NYHA I	122 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA I	23 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline NYHA II	293 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA II	197 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline NYHA III	98 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA IV	1 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline NYHA IV	1 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA III	44 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	Baseline NYHA Obtained Outside Window	4 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA II	42 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA I	118 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA IV	4 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA II	234 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA Missing For Other Reasons	388 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA III	55 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA Missing due to Death	40 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA IV	1 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA III	7 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA Missing due to Death	22 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	24 Month NYHA Missing For Other Reasons	129 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	12 Month NYHA Missing For Other Reasons	88 participants
MVP Pacing	Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time	36 Month NYHA Missing due to Death	57 participants

Comparison: A model with covariates for time and randomization arm was fit to test the null hypothesis that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. This analysis combined NYHA IV and Death into one category. The model included interaction terms for time and randomization arm.p-value: >0.05Cumulative Logits Model

Comparison: The null hypothesis for this analysis was the same as for the prior analysis: that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. In this analysis, however, death was considered a 5th category in addition to NYHA I-IV. An interaction term for time and randomization arm was also included.p-value: >0.05Cumulative Logit Model

Secondary

Heart Chamber Dimensions and Wall Thicknesses

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

Time frame: Baseline, 12, and 24 month visits

Arm	Measure	Group	Value (MEAN)	Dispersion
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	LV End Diastolic Dimension(LVEDD) (cm) at Baseline	5.9 centimeters (cm)	Standard Deviation 1
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	LVEDD (cm) at 12 Months	6 centimeters (cm)	Standard Deviation 0.9
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	LVEDD (cm) at 24 Months	6 centimeters (cm)	Standard Deviation 1
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	LV End Systolic Dimension (LVESD) (cm) at Baseline	4.9 centimeters (cm)	Standard Deviation 1.1
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	LVESD (cm) at 12 Months	4.7 centimeters (cm)	Standard Deviation 1.1
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	LVESD (cm) at 24 Months	4.8 centimeters (cm)	Standard Deviation 1.1
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	Septal Thickness (cm) at Baseline	1 centimeters (cm)	Standard Deviation 0.3
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	Septal Thickness (cm) at 12 Months	1 centimeters (cm)	Standard Deviation 0.3
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	Septal Thickness (cm) at 24 Months	1 centimeters (cm)	Standard Deviation 0.3
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	Posterior Wall Thickness (cm) at Baseline	1 centimeters (cm)	Standard Deviation 0.2
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	Posterior Wall Thickness (cm) at 12 Months	1 centimeters (cm)	Standard Deviation 0.2
VVI 40	Heart Chamber Dimensions and Wall Thicknesses	Posterior Wall Thickness (cm) at 24 Months	1 centimeters (cm)	Standard Deviation 0.2
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	Posterior Wall Thickness (cm) at 12 Months	1 centimeters (cm)	Standard Deviation 0.2
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	LV End Diastolic Dimension(LVEDD) (cm) at Baseline	6 centimeters (cm)	Standard Deviation 0.9
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	Septal Thickness (cm) at Baseline	1 centimeters (cm)	Standard Deviation 0.3
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	LVEDD (cm) at 12 Months	6 centimeters (cm)	Standard Deviation 0.9
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	Posterior Wall Thickness (cm) at Baseline	1 centimeters (cm)	Standard Deviation 0.2
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	LVEDD (cm) at 24 Months	5.9 centimeters (cm)	Standard Deviation 0.8
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	Septal Thickness (cm) at 12 Months	1 centimeters (cm)	Standard Deviation 0.3
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	LV End Systolic Dimension (LVESD) (cm) at Baseline	4.9 centimeters (cm)	Standard Deviation 1
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	Posterior Wall Thickness (cm) at 24 Months	1 centimeters (cm)	Standard Deviation 0.2
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	LVESD (cm) at 12 Months	4.9 centimeters (cm)	Standard Deviation 1
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	Septal Thickness (cm) at 24 Months	1 centimeters (cm)	Standard Deviation 0.2
MVP Pacing	Heart Chamber Dimensions and Wall Thicknesses	LVESD (cm) at 24 Months	4.8 centimeters (cm)	Standard Deviation 1.1

Comparison: A linear mixed model was fit for each of the followoing: LVEDD, LVESD, Septal Wall Thickness, and Posterior Wall Thickness; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.p-value: >0.1Mixed Models Analysis

Secondary

Hemodynamic Deceleration Time

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

Time frame: Baseline, 12, and 24 month visits

Arm	Measure	Group	Value (MEAN)	Dispersion
VVI 40	Hemodynamic Deceleration Time	Mitral Inflow - Deceleration Time at Baseline	194.6 milliseconds (ms)	Standard Deviation 50.6
VVI 40	Hemodynamic Deceleration Time	Mitral Inflow - Deceleration Time at 12 Months	206.8 milliseconds (ms)	Standard Deviation 54.7
VVI 40	Hemodynamic Deceleration Time	Mitral Inflow - Deceleration Time at 24 Months	208.0 milliseconds (ms)	Standard Deviation 54.6
MVP Pacing	Hemodynamic Deceleration Time	Mitral Inflow - Deceleration Time at Baseline	192.3 milliseconds (ms)	Standard Deviation 50.6
MVP Pacing	Hemodynamic Deceleration Time	Mitral Inflow - Deceleration Time at 12 Months	208.7 milliseconds (ms)	Standard Deviation 61
MVP Pacing	Hemodynamic Deceleration Time	Mitral Inflow - Deceleration Time at 24 Months	210.7 milliseconds (ms)	Standard Deviation 56.9

Comparison: A linear mixed model was fit for Mitral Inflow - Deceleration time; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.p-value: 0.949Mixed Models Analysis

Secondary

Hemodynamic Velocity Measures

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

Time frame: Baseline, 12, and 24 month visits

Arm	Measure	Group	Value (MEAN)	Dispersion
VVI 40	Hemodynamic Velocity Measures	TR Velocity at 12 Months	2.7 meters per second (m/s)	Standard Deviation 0.4
VVI 40	Hemodynamic Velocity Measures	Mitral Inflow - peak E at 24 Months	0.7 meters per second (m/s)	Standard Deviation 0.3
VVI 40	Hemodynamic Velocity Measures	Mitral Inflow - peak E at Baseline	0.8 meters per second (m/s)	Standard Deviation 0.2
VVI 40	Hemodynamic Velocity Measures	Mitral Inflow - peak A at Baseline	0.7 meters per second (m/s)	Standard Deviation 0.3
VVI 40	Hemodynamic Velocity Measures	TR Velocity at 24 Months	2.7 meters per second (m/s)	Standard Deviation 0.4
VVI 40	Hemodynamic Velocity Measures	Mitral Inflow - peak A at 12 Months	0.7 meters per second (m/s)	Standard Deviation 0.2
VVI 40	Hemodynamic Velocity Measures	Mitral Inflow - peak E at 12 Months	0.7 meters per second (m/s)	Standard Deviation 0.3
VVI 40	Hemodynamic Velocity Measures	Mitral Inflow - peak A at 24 Months	0.7 meters per second (m/s)	Standard Deviation 0.2
VVI 40	Hemodynamic Velocity Measures	Tricuspid Regurgitation (TR) Velocity at Baseline	2.7 meters per second (m/s)	Standard Deviation 0.4
MVP Pacing	Hemodynamic Velocity Measures	Mitral Inflow - peak A at 24 Months	0.8 meters per second (m/s)	Standard Deviation 0.2
MVP Pacing	Hemodynamic Velocity Measures	Tricuspid Regurgitation (TR) Velocity at Baseline	2.7 meters per second (m/s)	Standard Deviation 0.5
MVP Pacing	Hemodynamic Velocity Measures	TR Velocity at 12 Months	2.7 meters per second (m/s)	Standard Deviation 0.4
MVP Pacing	Hemodynamic Velocity Measures	TR Velocity at 24 Months	2.6 meters per second (m/s)	Standard Deviation 0.5
MVP Pacing	Hemodynamic Velocity Measures	Mitral Inflow - peak E at Baseline	0.8 meters per second (m/s)	Standard Deviation 0.3
MVP Pacing	Hemodynamic Velocity Measures	Mitral Inflow - peak E at 12 Months	0.7 meters per second (m/s)	Standard Deviation 0.3
MVP Pacing	Hemodynamic Velocity Measures	Mitral Inflow - peak E at 24 Months	0.7 meters per second (m/s)	Standard Deviation 0.3
MVP Pacing	Hemodynamic Velocity Measures	Mitral Inflow - peak A at Baseline	0.7 meters per second (m/s)	Standard Deviation 0.3
MVP Pacing	Hemodynamic Velocity Measures	Mitral Inflow - peak A at 12 Months	0.8 meters per second (m/s)	Standard Deviation 0.2

Comparison: A linear mixed model was fit for each of the following: TR Velocity, Mitral Inflow-peak E and Mitral Inflow-peak A; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.p-value: >0.1Mixed Models Analysis

Secondary

ICD-indicated Patients With Class I Pacemaker Indication.

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

Time frame: 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).

Arm	Measure	Group	Value (NUMBER)	Dispersion
VVI 40	ICD-indicated Patients With Class I Pacemaker Indication.	Class I Pacing Indication at Implant	220 participants	0.68
VVI 40	ICD-indicated Patients With Class I Pacemaker Indication.	No Class I Pacing Indication at Implant	1818 participants	0.7
VVI 40	ICD-indicated Patients With Class I Pacemaker Indication.	Class I Pacing Indication Status Not Recorded	13 participants	2.2

Secondary

Left Atrial (LA) and Mitral Regurgitation (MR) Areas

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

Time frame: Baseline, 12, and 24 month visits

Arm	Measure	Group	Value (MEAN)	Dispersion
VVI 40	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	Left Atrial (LA) Area at Baseline	22.7 centimeters squared (cm2)	Standard Deviation 5.8
VVI 40	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	LA Area at 12 Months	22.0 centimeters squared (cm2)	Standard Deviation 5.5
VVI 40	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	LA Area at 24 Months	22.0 centimeters squared (cm2)	Standard Deviation 6
VVI 40	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	Mitral Regurgitation (MR) Area at Baseline	4.8 centimeters squared (cm2)	Standard Deviation 4.3
VVI 40	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	MR Area at 12 Months	4.8 centimeters squared (cm2)	Standard Deviation 4.9
VVI 40	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	MR Area at 24 Months	5.0 centimeters squared (cm2)	Standard Deviation 4.5
MVP Pacing	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	MR Area at 12 Months	4.5 centimeters squared (cm2)	Standard Deviation 4.3
MVP Pacing	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	Left Atrial (LA) Area at Baseline	22.5 centimeters squared (cm2)	Standard Deviation 5.9
MVP Pacing	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	Mitral Regurgitation (MR) Area at Baseline	5.1 centimeters squared (cm2)	Standard Deviation 4.7
MVP Pacing	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	LA Area at 12 Months	21.9 centimeters squared (cm2)	Standard Deviation 6.4
MVP Pacing	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	MR Area at 24 Months	4.7 centimeters squared (cm2)	Standard Deviation 4
MVP Pacing	Left Atrial (LA) and Mitral Regurgitation (MR) Areas	LA Area at 24 Months	21.9 centimeters squared (cm2)	Standard Deviation 6.3

Comparison: A linear mixed model was fit for each of the following: Left Atrial Area and Mitral Regurgitation Area; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.p-value: >0.1Mixed Models Analysis

Secondary

Left Ventricular (LV) and Left Atrial (LA) Volumes

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

Time frame: Baseline, 12, and 24 month visits

Arm	Measure	Group	Value (MEAN)	Dispersion
VVI 40	Left Ventricular (LV) and Left Atrial (LA) Volumes	LA Volume at 24 Months	82.3 milliliters (mL)	Standard Deviation 32
VVI 40	Left Ventricular (LV) and Left Atrial (LA) Volumes	LV End Systolic Volume (LVESV) at Baseline	127.6 milliliters (mL)	Standard Deviation 65.5
VVI 40	Left Ventricular (LV) and Left Atrial (LA) Volumes	LVESV at 12 Months	108.9 milliliters (mL)	Standard Deviation 59.7
VVI 40	Left Ventricular (LV) and Left Atrial (LA) Volumes	LVESV at 24 Months	116.5 milliliters (mL)	Standard Deviation 62.6
VVI 40	Left Ventricular (LV) and Left Atrial (LA) Volumes	LV End Diastolic Volume (LVEDV) at Baseline	189.8 milliliters (mL)	Standard Deviation 72.7
VVI 40	Left Ventricular (LV) and Left Atrial (LA) Volumes	LVEDV at 12 Months	170.6 milliliters (mL)	Standard Deviation 68.6
VVI 40	Left Ventricular (LV) and Left Atrial (LA) Volumes	LVEDV at 24 Months	179.0 milliliters (mL)	Standard Deviation 71.8
VVI 40	Left Ventricular (LV) and Left Atrial (LA) Volumes	Left Atrial (LA) Volume at Baseline	75.4 milliliters (mL)	Standard Deviation 26.1
VVI 40	Left Ventricular (LV) and Left Atrial (LA) Volumes	LA Volume at 12 Months	74.5 milliliters (mL)	Standard Deviation 28.3
MVP Pacing	Left Ventricular (LV) and Left Atrial (LA) Volumes	Left Atrial (LA) Volume at Baseline	74.5 milliliters (mL)	Standard Deviation 26.5
MVP Pacing	Left Ventricular (LV) and Left Atrial (LA) Volumes	LVEDV at 12 Months	163.2 milliliters (mL)	Standard Deviation 58.7
MVP Pacing	Left Ventricular (LV) and Left Atrial (LA) Volumes	LV End Systolic Volume (LVESV) at Baseline	121.2 milliliters (mL)	Standard Deviation 54.4
MVP Pacing	Left Ventricular (LV) and Left Atrial (LA) Volumes	LA Volume at 24 Months	77.4 milliliters (mL)	Standard Deviation 27.7
MVP Pacing	Left Ventricular (LV) and Left Atrial (LA) Volumes	LVESV at 12 Months	105.8 milliliters (mL)	Standard Deviation 53.4
MVP Pacing	Left Ventricular (LV) and Left Atrial (LA) Volumes	LVEDV at 24 Months	165.8 milliliters (mL)	Standard Deviation 57.8
MVP Pacing	Left Ventricular (LV) and Left Atrial (LA) Volumes	LVESV at 24 Months	108.7 milliliters (mL)	Standard Deviation 52.8
MVP Pacing	Left Ventricular (LV) and Left Atrial (LA) Volumes	LA Volume at 12 Months	73.6 milliliters (mL)	Standard Deviation 27.9
MVP Pacing	Left Ventricular (LV) and Left Atrial (LA) Volumes	LV End Diastolic Volume (LVEDV) at Baseline	182.5 milliliters (mL)	Standard Deviation 60.6

Comparison: A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values for left ventricular end diastolic volume (LVEDV) over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.p-value: 0.0424Mixed Models Analysis

Comparison: Similar models were fit for left ventricle (LV) End Systolic Volume and Left Atrial Volume.p-value: >0.1Mixed Models Analysis

Secondary

Left Ventricular (LV) Ejection Fraction and Fractional Shortening

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%.

Time frame: Baseline, 12, and 24 month visits

Arm	Measure	Group	Value (MEAN)	Dispersion
VVI 40	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Fractional Shortening (%) at Baseline	19.5 percentage of LV unit	Standard Deviation 9.2
VVI 40	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Fractional Shortening (%) at 12 Months	21.6 percentage of LV unit	Standard Deviation 8.4
VVI 40	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Fractional Shortening (%) at 24 Months	21.3 percentage of LV unit	Standard Deviation 9.1
VVI 40	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Ejection Fraction (%) at Baseline	35.3 percentage of LV unit	Standard Deviation 11.9
VVI 40	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Ejection Fraction (%) at 12 Months	38.8 percentage of LV unit	Standard Deviation 11.9
VVI 40	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Ejection Fraction (%) at 24 Months	37.6 percentage of LV unit	Standard Deviation 12.5
MVP Pacing	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Ejection Fraction (%) at 12 Months	37.3 percentage of LV unit	Standard Deviation 11.8
MVP Pacing	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Fractional Shortening (%) at Baseline	18.8 percentage of LV unit	Standard Deviation 8.5
MVP Pacing	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Ejection Fraction (%) at Baseline	35.5 percentage of LV unit	Standard Deviation 11.6
MVP Pacing	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Fractional Shortening (%) at 12 Months	20.1 percentage of LV unit	Standard Deviation 8
MVP Pacing	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Ejection Fraction (%) at 24 Months	36.7 percentage of LV unit	Standard Deviation 12
MVP Pacing	Left Ventricular (LV) Ejection Fraction and Fractional Shortening	LV Fractional Shortening (%) at 24 Months	20.6 percentage of LV unit	Standard Deviation 8.6

Comparison: A linear mixed model was fit for each of the following: LV Ejection Fraction and LV Fractional Shortening; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.p-value: >0.1Mixed Models Analysis

Secondary

Left Ventricular (LV) Sphericity Index

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.

Time frame: Baseline, 12, and 24 month visits

Arm	Measure	Group	Value (MEAN)	Dispersion
VVI 40	Left Ventricular (LV) Sphericity Index	Left Ventricular (LV) Sphericity Index at Baseline	1.5 Ratio	Standard Deviation 0.2
VVI 40	Left Ventricular (LV) Sphericity Index	LV Sphericity Index at 12 Months	1.5 Ratio	Standard Deviation 0.2
VVI 40	Left Ventricular (LV) Sphericity Index	LV Sphericity Index at 24 Months	1.6 Ratio	Standard Deviation 0.2
MVP Pacing	Left Ventricular (LV) Sphericity Index	Left Ventricular (LV) Sphericity Index at Baseline	1.5 Ratio	Standard Deviation 0.2
MVP Pacing	Left Ventricular (LV) Sphericity Index	LV Sphericity Index at 12 Months	1.5 Ratio	Standard Deviation 0.2
MVP Pacing	Left Ventricular (LV) Sphericity Index	LV Sphericity Index at 24 Months	1.5 Ratio	Standard Deviation 0.2

Comparison: A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values of Left Ventricular Sphericity Index over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.p-value: 0.0418Mixed Models Analysis

Secondary

Medication Usage Affecting Heart Rate and Atrioventricular (AV) Conduction

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

Time frame: Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months

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

Secondary

Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History

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

Time frame: 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.

Arm	Measure	Value (NUMBER)
VVI 40	Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History	445 participants
MVP Pacing	Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History	444 participants

Comparison: This analysis compared the hazard rates for clinically important AF (defined as a calendar day with \>20 hour of AT/AF as measured by the device). The null hypothesis was that this hazard rate for patients with MVP was equal to or greater than that of patients with VVI 40. The pre-specified model had Arm as a covariate, and accounted for time to first event and time between successive events per subject.p-value: 0.716695% CI: [1.22, 3]Andersen-Gill model

Comparison: This analysis compared the percentage of days with \>20 hours of AT/AF as measured by the device(definition of clinically important AF) between arms. The null hypothesis was that this percentage of days for patients with MVP was equal or greater to that of patients with VVI 40.95% CI: [-100, 0.8]Bootstrap Confidence Interval

Comparison: This analysis tested the null hypothesis that the hazard rate for development of persistent AF(defined as 2 consecutive visits presenting with AT/AF, 7 consecutive days of 22 or more hours per day of AT/AF, or \< 7 such days due to a cardioversion) in patients with MVP and no pacing indication was equal to or greater than that of similar patients with VVI 40.p-value: 0.325Log Rank

Comparison: This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) through 6 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.95% CI: [0, 0.145]Bootstrap Confidence Interval

Comparison: This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 6 to 12 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.95% CI: [0, 0.227]Bootstrap Confidence Interval

Comparison: This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 12 to 24 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.95% CI: [0, 0.261]Bootstrap Confidence Interval

Comparison: This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 24 to 36 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.95% CI: [-0.1, 0.11]Bootstrap Confidence Interval

Secondary

Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes

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

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

Arm	Measure	Group	Value (NUMBER)
VVI 40	Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes	True VT/VF	0.170 Annualized Episodes per Patient Month
VVI 40	Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes	Inappropriately detected non-VT/VF	0.038 Annualized Episodes per Patient Month
MVP Pacing	Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes	Inappropriately detected non-VT/VF	0.055 Annualized Episodes per Patient Month
MVP Pacing	Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes	True VT/VF	0.155 Annualized Episodes per Patient Month

Comparison: A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of inappropriately detected non-VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.95% CI: [0.017, 0.036]Bootstrap Confidence Interval

Comparison: The pre-specified analysis called for a comparison of the hazard rates of true VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (values less than one favor MVP) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.95% CI: [0.949, 1.209]Andersen-Gill model

Comparison: A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of true VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.95% CI: [-0.015, 0.033]Bootstrap Confidence Interval

Comparison: The pre-specified analysis called for a comparison of the hazard rates of inappropriately detected non-VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (MVP in numerator) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.95% CI: [1.31, 1.858]Andersen-Gill model

Secondary

Occurrence of Worsening Heart Failure-related Adverse Events

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

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

Arm	Measure	Group	Value (NUMBER)
VVI 40	Occurrence of Worsening Heart Failure-related Adverse Events	Number of Participants with Events	96 participants/events
VVI 40	Occurrence of Worsening Heart Failure-related Adverse Events	Number of Events	193 participants/events
MVP Pacing	Occurrence of Worsening Heart Failure-related Adverse Events	Number of Participants with Events	108 participants/events
MVP Pacing	Occurrence of Worsening Heart Failure-related Adverse Events	Number of Events	190 participants/events

Comparison: This is a multiple events survival analysis, and so the time from randomization to first HF event, time between successive HF events, and time from last HF event to last follow-up visit was determined for each subject. Since non-inferiority analysis is intended to prove that one therapy is equivalent or superior to another therapy, the null hypothesis being tested is that the worsening HF hazard rate for patients with MVP programming is greater than that of patients with VVI 40 programming.95% CI: [1.029, 1.381]Andersen-Gill Model

Secondary

Percent Ventricular Pacing

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

Time frame: Enrollment, 6, 12, 24 and 36 month visits

Arm	Measure	Group	Value (MEAN)	Dispersion
VVI 40	Percent Ventricular Pacing	Baseline to 6 Months	0.7 Percent pacing	Standard Deviation 3.7
VVI 40	Percent Ventricular Pacing	Baseline to 12 Months	1.1 Percent pacing	Standard Deviation 5.5
VVI 40	Percent Ventricular Pacing	Baseline to 24 Months	1.8 Percent pacing	Standard Deviation 8
VVI 40	Percent Ventricular Pacing	Baseline to 36 Months	3.4 Percent pacing	Standard Deviation 13.8
MVP Pacing	Percent Ventricular Pacing	Baseline to 36 Months	1.5 Percent pacing	Standard Deviation 6.9
MVP Pacing	Percent Ventricular Pacing	Baseline to 6 Months	0.8 Percent pacing	Standard Deviation 3.4
MVP Pacing	Percent Ventricular Pacing	Baseline to 24 Months	1.6 Percent pacing	Standard Deviation 6.4
MVP Pacing	Percent Ventricular Pacing	Baseline to 12 Months	1.0 Percent pacing	Standard Deviation 4

Comparison: All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 6 months post-implant for patients with MVP programming and was greater than or equal to that of patients with VVI 40 programming.p-value: 0.9791Wilcoxon (Mann-Whitney)

Comparison: All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 12 months post-implant for patients with MVP programming was greater than or equal to that of patients with VVI 40 programming.p-value: 0.8984Wilcoxon (Mann-Whitney)

Comparison: All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 24 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.p-value: 0.7144Wilcoxon (Mann-Whitney)

Comparison: All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 36 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.p-value: 0.5165Wilcoxon (Mann-Whitney)

Secondary

Quality of Life (QOL) Score

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)

Time frame: Baseline, 12, 24, and 36 month visits

Arm	Measure	Group	Value (MEAN)	Dispersion
VVI 40	Quality of Life (QOL) Score	KCCQ Physical Limitation(12 Mo. -Baseline Change)	0.3 Units on a scale	Standard Deviation 25.8
VVI 40	Quality of Life (QOL) Score	KCCQ Total Symptoms(36 Mo. -Baseline Change)	-7.2 Units on a scale	Standard Deviation 36.9
VVI 40	Quality of Life (QOL) Score	KCCQ Symptom Stability(36 Mo. -Baseline Change)	-10.8 Units on a scale	Standard Deviation 29
VVI 40	Quality of Life (QOL) Score	KCCQ Quality of Life(24 Mo. -Baseline Change)	11.3 Units on a scale	Standard Deviation 35.7
VVI 40	Quality of Life (QOL) Score	KCCQ Self-Efficacy(24 Mo. -Baseline Change)	-0.9 Units on a scale	Standard Deviation 34.1
VVI 40	Quality of Life (QOL) Score	KCCQ Symptom Frequency(12 Mo. -Baseline Change)	4.7 Units on a scale	Standard Deviation 27.8
VVI 40	Quality of Life (QOL) Score	KCCQ Self-Efficacy(36 Mo. -Baseline Change)	-12.6 Units on a scale	Standard Deviation 43.2
VVI 40	Quality of Life (QOL) Score	KCCQ Physical Limitation(24 Mo. -Baseline Change)	-2.2 Units on a scale	Standard Deviation 28.5
VVI 40	Quality of Life (QOL) Score	KCCQ Quality of Life(12 Mo. -Baseline Change)	12.9 Units on a scale	Standard Deviation 31.8
VVI 40	Quality of Life (QOL) Score	KCCQ Symptom Frequency(24 Mo. -Baseline Change)	2.2 Units on a scale	Standard Deviation 31.9
VVI 40	Quality of Life (QOL) Score	KCCQ Social Limitation(12 Mo.-Baseline Change)	5.6 Units on a scale	Standard Deviation 31.7
VVI 40	Quality of Life (QOL) Score	KCCQ Quality of Life(36 Mo. -Baseline Change)	0.7 Units on a scale	Standard Deviation 39.4
VVI 40	Quality of Life (QOL) Score	KCCQ Symptom Frequency(36 Mo. -Baseline Change)	-7.1 Units on a scale	Standard Deviation 37.4
VVI 40	Quality of Life (QOL) Score	KCCQ Social Limitation(24 Mo.-Baseline Change)	3.4 Units on a scale	Standard Deviation 35.9
VVI 40	Quality of Life (QOL) Score	KCCQ Physical Limitation(36 Mo. -Baseline Change)	-11.0 Units on a scale	Standard Deviation 32.5
VVI 40	Quality of Life (QOL) Score	KCCQ Social Limitation(36 Mo.-Baseline Change)	-6.4 Units on a scale	Standard Deviation 40.7
VVI 40	Quality of Life (QOL) Score	KCCQ Symptom Burden(12 Mo. -Baseline Change)	4.8 Units on a scale	Standard Deviation 27.7
VVI 40	Quality of Life (QOL) Score	KCCQ Overall Summary(12 Mo.-Baseline Change)	6.1 Units on a scale	Standard Deviation 25.1
VVI 40	Quality of Life (QOL) Score	MLWHFQ (12 Month - Baseline Change)	-5.8 Units on a scale	Standard Deviation 24.6
VVI 40	Quality of Life (QOL) Score	KCCQ Overall Summary(24 Mo.-Baseline Change)	3.7 Units on a scale	Standard Deviation 29.4
VVI 40	Quality of Life (QOL) Score	KCCQ Symptom Burden(24 Mo. -Baseline Change)	2.4 Units on a scale	Standard Deviation 32.3
VVI 40	Quality of Life (QOL) Score	KCCQ Overall Summary(36 Mo.-Baseline Change)	-5.1 Units on a scale	Standard Deviation 34.7
VVI 40	Quality of Life (QOL) Score	KCCQ Symptom Stability(12 Mo. -Baseline Change)	1.8 Units on a scale	Standard Deviation 28.5
VVI 40	Quality of Life (QOL) Score	KCCQ Clinical Summary(12 Mo.-Baseline Change)	2.8 Units on a scale	Standard Deviation 24.1
VVI 40	Quality of Life (QOL) Score	KCCQ Symptom Burden(36 Mo. -Baseline Change)	-7.3 Units on a scale	Standard Deviation 38.2
VVI 40	Quality of Life (QOL) Score	KCCQ Clinical Summary(24 Mo.-Baseline Change)	0.2 Units on a scale	Standard Deviation 28.1
VVI 40	Quality of Life (QOL) Score	MLWHFQ (36 Month - Baseline Change)	8.4 Units on a scale	Standard Deviation 37
VVI 40	Quality of Life (QOL) Score	KCCQ Clinical Summary(36 Mo.-Baseline Change)	-8.4 Units on a scale	Standard Deviation 33.8
VVI 40	Quality of Life (QOL) Score	KCCQ Total Symptoms(12 Mo. -Baseline Change)	4.7 Units on a scale	Standard Deviation 26.7
VVI 40	Quality of Life (QOL) Score	KCCQ Symptom Stability(24 Mo. -Baseline Change)	-1.5 Units on a scale	Standard Deviation 28.5
VVI 40	Quality of Life (QOL) Score	MLWHFQ (24 Month - Baseline Change)	-2 Units on a scale	Standard Deviation 30.6
VVI 40	Quality of Life (QOL) Score	KCCQ Total Symptoms(24 Mo. -Baseline Change)	2.3 Units on a scale	Standard Deviation 31.2
VVI 40	Quality of Life (QOL) Score	KCCQ Self-Efficacy(12 Mo. -Baseline Change)	1.9 Units on a scale	Standard Deviation 28.9
MVP Pacing	Quality of Life (QOL) Score	MLWHFQ (36 Month - Baseline Change)	5.9 Units on a scale	Standard Deviation 32.1
MVP Pacing	Quality of Life (QOL) Score	KCCQ Quality of Life(36 Mo. -Baseline Change)	0.9 Units on a scale	Standard Deviation 33.1
MVP Pacing	Quality of Life (QOL) Score	KCCQ Physical Limitation(12 Mo. -Baseline Change)	4.1 Units on a scale	Standard Deviation 28.5
MVP Pacing	Quality of Life (QOL) Score	KCCQ Physical Limitation(24 Mo. -Baseline Change)	-0.1 Units on a scale	Standard Deviation 31.4
MVP Pacing	Quality of Life (QOL) Score	KCCQ Physical Limitation(36 Mo. -Baseline Change)	-11.0 Units on a scale	Standard Deviation 30.8
MVP Pacing	Quality of Life (QOL) Score	KCCQ Symptom Stability(12 Mo. -Baseline Change)	3.1 Units on a scale	Standard Deviation 27.1
MVP Pacing	Quality of Life (QOL) Score	KCCQ Symptom Stability(24 Mo. -Baseline Change)	-0.6 Units on a scale	Standard Deviation 30.7
MVP Pacing	Quality of Life (QOL) Score	KCCQ Symptom Stability(36 Mo. -Baseline Change)	-10.5 Units on a scale	Standard Deviation 33.6
MVP Pacing	Quality of Life (QOL) Score	KCCQ Symptom Frequency(12 Mo. -Baseline Change)	5.1 Units on a scale	Standard Deviation 27.4
MVP Pacing	Quality of Life (QOL) Score	KCCQ Symptom Frequency(24 Mo. -Baseline Change)	1.7 Units on a scale	Standard Deviation 31.8
MVP Pacing	Quality of Life (QOL) Score	KCCQ Symptom Frequency(36 Mo. -Baseline Change)	-10.1 Units on a scale	Standard Deviation 33.1
MVP Pacing	Quality of Life (QOL) Score	KCCQ Symptom Burden(12 Mo. -Baseline Change)	5.9 Units on a scale	Standard Deviation 28.6
MVP Pacing	Quality of Life (QOL) Score	KCCQ Symptom Burden(24 Mo. -Baseline Change)	3.2 Units on a scale	Standard Deviation 33
MVP Pacing	Quality of Life (QOL) Score	KCCQ Symptom Burden(36 Mo. -Baseline Change)	-8.6 Units on a scale	Standard Deviation 34.3
MVP Pacing	Quality of Life (QOL) Score	KCCQ Total Symptoms(12 Mo. -Baseline Change)	5.5 Units on a scale	Standard Deviation 26.9
MVP Pacing	Quality of Life (QOL) Score	KCCQ Total Symptoms(24 Mo. -Baseline Change)	2.4 Units on a scale	Standard Deviation 31.4
MVP Pacing	Quality of Life (QOL) Score	KCCQ Total Symptoms(36 Mo. -Baseline Change)	-9.3 Units on a scale	Standard Deviation 33
MVP Pacing	Quality of Life (QOL) Score	KCCQ Self-Efficacy(12 Mo. -Baseline Change)	4.9 Units on a scale	Standard Deviation 30.5
MVP Pacing	Quality of Life (QOL) Score	KCCQ Self-Efficacy(24 Mo. -Baseline Change)	-0.2 Units on a scale	Standard Deviation 35.9
MVP Pacing	Quality of Life (QOL) Score	KCCQ Self-Efficacy(36 Mo. -Baseline Change)	-12.5 Units on a scale	Standard Deviation 43.5
MVP Pacing	Quality of Life (QOL) Score	KCCQ Quality of Life(12 Mo. -Baseline Change)	16.6 Units on a scale	Standard Deviation 32.1
MVP Pacing	Quality of Life (QOL) Score	KCCQ Quality of Life(24 Mo. -Baseline Change)	14.6 Units on a scale	Standard Deviation 35.5
MVP Pacing	Quality of Life (QOL) Score	KCCQ Social Limitation(12 Mo.-Baseline Change)	8.1 Units on a scale	Standard Deviation 33.5
MVP Pacing	Quality of Life (QOL) Score	KCCQ Social Limitation(24 Mo.-Baseline Change)	6.1 Units on a scale	Standard Deviation 36.4
MVP Pacing	Quality of Life (QOL) Score	KCCQ Social Limitation(36 Mo.-Baseline Change)	-2.3 Units on a scale	Standard Deviation 32.2
MVP Pacing	Quality of Life (QOL) Score	KCCQ Overall Summary(12 Mo.-Baseline Change)	8.7 Units on a scale	Standard Deviation 26.7
MVP Pacing	Quality of Life (QOL) Score	KCCQ Overall Summary(24 Mo.-Baseline Change)	5.7 Units on a scale	Standard Deviation 30.2
MVP Pacing	Quality of Life (QOL) Score	KCCQ Overall Summary(36 Mo.-Baseline Change)	-5.4 Units on a scale	Standard Deviation 28.7
MVP Pacing	Quality of Life (QOL) Score	KCCQ Clinical Summary(12 Mo.-Baseline Change)	4.9 Units on a scale	Standard Deviation 25.9
MVP Pacing	Quality of Life (QOL) Score	KCCQ Clinical Summary(24 Mo.-Baseline Change)	1.2 Units on a scale	Standard Deviation 29.3
MVP Pacing	Quality of Life (QOL) Score	KCCQ Clinical Summary(36 Mo.-Baseline Change)	-9.7 Units on a scale	Standard Deviation 29.6
MVP Pacing	Quality of Life (QOL) Score	MLWHFQ (12 Month - Baseline Change)	-7.9 Units on a scale	Standard Deviation 28.5
MVP Pacing	Quality of Life (QOL) Score	MLWHFQ (24 Month - Baseline Change)	-4 Units on a scale	Standard Deviation 31.7

Comparison: For the KCCQ Physical Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.p-value: 0.0073Wilcoxon (Mann-Whitney)

Comparison: For the KCCQ Symptom Stability Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.p-value: 0.2493Wilcoxon (Mann-Whitney)

Comparison: For the KCCQ Symptom Frequency Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.p-value: 0.7728Wilcoxon (Mann-Whitney)

Comparison: For the KCCQ Symptom Burden Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.p-value: 0.3082Wilcoxon (Mann-Whitney)

Comparison: For the KCCQ Total Symptom Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.p-value: 0.5422Wilcoxon (Mann-Whitney)

Comparison: For the KCCQ Self-Efficacy Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.p-value: 0.0851Wilcoxon (Mann-Whitney)

Comparison: For the KCCQ Quality of Life Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.p-value: 0.0502Wilcoxon (Mann-Whitney)

Comparison: For the KCCQ Social Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.p-value: 0.0463Wilcoxon (Mann-Whitney)

Comparison: For the KCCQ Overall Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.p-value: 0.0227Wilcoxon (Mann-Whitney)

Comparison: For the KCCQ Overall Clinical Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.p-value: 0.0582Wilcoxon (Mann-Whitney)

Comparison: The 10 KCCQ analyses were repeated comparing changes from baseline to 24 months between arms. Again if a subject died prior to their 24 month visit, a value of 0 was imputed for their 24 month score.p-value: >0.15Wilcoxon (Mann-Whitney)

Comparison: The 10 KCCQ analyses were repeated comparing changes from baseline to 36 months between arms. Again if a subject died prior to their 36 month visit, a value of 0 was imputed for their 36 month score.p-value: >0.15Wilcoxon (Mann-Whitney)

Comparison: The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 12 months was compared using a two-sided test. If a subject died before their 12 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 12 month score.p-value: 0.1399Wilcoxon (Mann-Whitney)

Comparison: The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 24 months was compared using a two-sided test. If a subject died before their 24 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 24 month score.p-value: 0.3573Wilcoxon (Mann-Whitney)

Comparison: The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 36 months was compared using a two-sided test. If a subject died before their 36 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 36 month score.p-value: 0.5183Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026

Managed Ventricular Pacing (MVP) Trial

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure (HF) Hospitalizations.

All Cause Mortality

Composite Mitral Regurgitation (MR) Severity Score

Development of a Pacing Indication During the Study

Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time

Heart Chamber Dimensions and Wall Thicknesses

Hemodynamic Deceleration Time

Hemodynamic Velocity Measures

ICD-indicated Patients With Class I Pacemaker Indication.

Left Atrial (LA) and Mitral Regurgitation (MR) Areas

Left Ventricular (LV) and Left Atrial (LA) Volumes

Left Ventricular (LV) Ejection Fraction and Fractional Shortening

Left Ventricular (LV) Sphericity Index

Medication Usage Affecting Heart Rate and Atrioventricular (AV) Conduction

Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History

Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes

Occurrence of Worsening Heart Failure-related Adverse Events

Percent Ventricular Pacing

Quality of Life (QOL) Score