Managed Ventricular Pacing ("MVP") Trial

Medtronic

Status

Terminated

Conditions

Heart Disease

Treatments

Device: ICD (Implantable Cardioverter Defibrillator)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00281099

240

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,031 patients

Sex

All

Ages

18+ years old

Volunteers

No 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