Managed Ventricular Pacing ("MVP") Trial

Stopped early · Not applicable

Conditions studied: Heart Disease

In brief

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.

Key facts

Study ID

NCT00281099

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

1031

Starts

2004-10-01

Expected to finish

2008-07-01

Last updated by the study team

2010-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — North Little Rock, Arkansas, United States
• Study site — Brandon, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Silver Spring, Maryland, United States
• Study site — Takoma Park, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Lansing, Michigan, United States
• Study site — Marquette, Michigan, United States
• Study site — Petoskey, Michigan, United States
• Study site — Coon Rapids, Minnesota, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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