Managed Ventricular Pacing ("MVP") Trial

Not Applicable

Terminated

Conditions: Heart Disease

Interventions: Device: ICD (Implantable Cardioverter Defibrillator)

Registration Number: NCT00281099

Lead Sponsor: Medtronic Cardiac Rhythm and 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1031

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VVI 40 pacing	ICD (Implantable Cardioverter Defibrillator)	Backup ventricular pacing (VVI) at 40 beats per minute
MVP pacing	ICD (Implantable Cardioverter Defibrillator)	Managed ventricular pacing (MVP) at 60 beats per minute

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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.
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