Heart Failure Clinical Trial
Managed Ventricular Pacing (“MVP”) Trial
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.
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.
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
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There is 1 Location for this study
Anchorage Alaska, , United States
Little Rock Arkansas, , United States
North Little Rock Arkansas, , United States
Brandon Florida, , United States
Clearwater Florida, , United States
Fort Lauderdale Florida, , United States
Naples Florida, , United States
Pensacola Florida, , United States
Atlanta Georgia, , United States
Savannah Georgia, , United States
Indianapolis Indiana, , United States
Des Moines Iowa, , United States
Kansas City Kansas, , United States
Lexington Kentucky, , United States
Louisville Kentucky, , United States
New Orleans Louisiana, , United States
Baltimore Maryland, , United States
Silver Spring Maryland, , United States
Takoma Park Maryland, , United States
Detroit Michigan, , United States
Lansing Michigan, , United States
Marquette Michigan, , United States
Petoskey Michigan, , United States
Coon Rapids Minnesota, , United States
St. Paul Minnesota, , United States
St. Louis Missouri, , United States
Lebanon New Hampshire, , United States
Hackensack New Jersey, , United States
Newark New Jersey, , United States
New Hyde Park New York, , United States
New York New York, , United States
Gastonia North Carolina, , United States
Raleigh North Carolina, , United States
Mayfield Hts. Ohio, , United States
Oklahoma City Oklahoma, , United States
Tulsa Oklahoma, , United States
Allentown Pennsylvania, , United States
Philadelphia Pennsylvania, , United States
Columbia South Carolina, , United States
Knoxville Tennessee, , United States
Nashville Tennessee, , United States
Austin Texas, , United States
Fort Worth Texas, , United States
Houston Texas, , United States
Taylorville Utah, , United States
Charlottesville Virginia, , United States
Norfolk Virginia, , United States
Richmond Virginia, , United States
Morgantown West Virginia, , United States
Milwaukee Wisconsin, , United States
St. Pölten , , Austria
Edmonton Alberta, , Canada
Vancouver British Columbia, , Canada
Victoria British Columbia, , Canada
Ottawa Ontario, , Canada
Montreal Quebec, , Canada
Ste-Foy Quebec, , Canada
Aarus , , Denmark
Le Chesnay , , France
Lille , , France
Bad Berka , , Germany
Franfurt am Main , , Germany
Heidelberg , , Germany
Homburg/Saar , , Germany
Kiel , , Germany
Haifa , , Israel
Milano , , Israel
Tel Aviv , , Israel
Milan , , Italy
Tromso , , Norway
Valencia , , Spain
Zürich , , Switzerland
London , , United Kingdom
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