MVP Trial (Managed Ventricular Pacing ("MVP") Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute ("VVI 40") Pacing Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Disease
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 1031
- Primary Endpoint
- All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure ("HF") Hospitalizations.
- Status
- Terminated
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure ("HF") Hospitalizations.
Time Frame: 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 Outcomes
- Occurrence of Worsening Heart Failure-related Adverse Events(Enrollment to last visit (up to 45 months post-randomization))
- Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time(Baseline, 12, 24 and 36 month visits)
- Heart Chamber Dimensions and Wall Thicknesses(Baseline, 12, and 24 month visits)
- Left Ventricular (LV) Ejection Fraction and Fractional Shortening(Baseline, 12, and 24 month visits)
- Left Ventricular (LV) and Left Atrial (LA) Volumes(Baseline, 12, and 24 month visits)
- Left Ventricular (LV) Sphericity Index(Baseline, 12, and 24 month visits)
- Hemodynamic Velocity Measures(Baseline, 12, and 24 month visits)
- Hemodynamic Deceleration Time(Baseline, 12, and 24 month visits)
- Left Atrial (LA) and Mitral Regurgitation (MR) Areas(Baseline, 12, and 24 month visits)
- Composite Mitral Regurgitation (MR) Severity Score(Baseline, 12, and 24 month visits)
- 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))
- 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))
- Development of a Pacing Indication During the Study(Enrollment to last visit (up to 45 months post-randomization))
- Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction(Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months)
- Percent Ventricular Pacing(Enrollment, 6, 12, 24 and 36 month visits)
- Quality of Life ("QOL") Score(Baseline, 12, 24, and 36 month visits)
- All Cause Mortality(Enrollment to last visit (up to 45 months post-randomization) or death)
- ICD-indicated Patients With Class I Pacemaker Indication.(Period of time prior to patient consent when considering patient for Implant/Enrollment)