Managed Ventricular Pacing (MVP) Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Disease

Intervention / Treatment
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* Device: ICD (Implantable Cardioverter Defibrillator)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VVI 40 pacing<br>Backup ventricular pacing (VVI) at 40 beats per minute | Device: ICD (Implantable Cardioverter Defibrillator)<br>* VVI 40 vs. MVP<br>* Other names: EnTrust™;|
| Active Comparator: MVP pacing<br>Managed ventricular pacing (MVP) at 60 beats per minute | Device: ICD (Implantable Cardioverter Defibrillator)<br>* VVI 40 vs. MVP<br>* Other names: EnTrust™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Enrollment to last visit (up to 45 months post-randomization) or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Enrollment to last visit (up to 45 months post-randomization) | 
| 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. | Baseline, 12, 24 and 36 month visits | 
| Heart Chamber Dimensions and Wall Thicknesses | Echocardiogram measures for each endpoint were obtained at multiple time points. | Baseline, 12, and 24 month visits | 
| 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%. | Baseline, 12, and 24 month visits | 
| Left Ventricular (LV) and Left Atrial (LA) Volumes | Echocardiogram measures for each endpoint were obtained at multiple time points. | Baseline, 12, and 24 month visits | 
| 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. | Baseline, 12, and 24 month visits | 
| Hemodynamic Velocity Measures | Echocardiogram measures for each endpoint were obtained at multiple time points. | Baseline, 12, and 24 month visits | 
| Hemodynamic Deceleration Time | Echocardiogram measures for each endpoint were obtained at multiple time points. | Baseline, 12, and 24 month visits | 
| Left Atrial (LA) and Mitral Regurgitation (MR) Areas | Echocardiogram measures for each endpoint were obtained at multiple time points. | Baseline, 12, and 24 month visits | 
| 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. | Baseline, 12, and 24 month visits | 
| Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes | Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF | Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization) | 
| 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: 2 consecutive visits in which the patient presents with AF 7 consecutive days of at least 22 hours per day of AT/AF 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 | Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization) | 
| 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. | Enrollment to last visit (up to 45 months post-randomization) | 
| 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. | Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months | 
| Percent Ventricular Pacing | The percentage of a patients' ventricular beats that were paced by the device. | Enrollment, 6, 12, 24 and 36 month visits | 
| 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) | Baseline, 12, 24, and 36 month visits | 
| All Cause Mortality | Death from any cause | Enrollment to last visit (up to 45 months post-randomization) or death | 
| 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 | Period of time prior to patient consent when considering patient for Implant/Enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, Pacing, Heart Failure