Managed Ventricular Pacing ("MVP") Trial

NCT ID: NCT00281099

Last Updated: 2010-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1031 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-07-31

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.

Conditions

Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

VVI 40 pacing

Backup ventricular pacing (VVI) at 40 beats per minute

Group Type: ACTIVE_COMPARATOR

ICD (Implantable Cardioverter Defibrillator)

Intervention Type: DEVICE

VVI 40 vs. MVP

MVP pacing

Managed ventricular pacing (MVP) at 60 beats per minute

Group Type: ACTIVE_COMPARATOR

ICD (Implantable Cardioverter Defibrillator)

Intervention Type: DEVICE

VVI 40 vs. MVP

Interventions

ICD (Implantable Cardioverter Defibrillator)

VVI 40 vs. MVP

Intervention Type: DEVICE

Other Intervention Names

Intrinsic™; EnTrust™

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Medtronic CRDM

Principal Investigators

Michael O Sweeney

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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

Saint 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

Sankt 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

Tromsø, , Norway

Valencia, , Spain

Zurich, , Switzerland

London, , United Kingdom

Countries

United States; Austria; Canada; Denmark; France; Germany; Israel; Italy; Norway; Spain; Switzerland; United Kingdom

References

Sweeney MO, Ellenbogen KA, Tang AS, Whellan D, Mortensen PT, Giraldi F, Sandler DA, Sherfesee L, Sheldon T; Managed Ventricular Pacing Versus VVI 40 Pacing Trial Investigators. Atrial pacing or ventricular backup-only pacing in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Nov;7(11):1552-60. doi: 10.1016/j.hrthm.2010.05.038. Epub 2010 Jun 4.

Reference Type: DERIVED

PMID: 20685401 (View on PubMed)

Other Identifiers

240

Identifier Type: -

Identifier Source: org_study_id