Managed Ventricular Pacing ("MVP") Trial

NCT00281099 | Terminated Results DMC

• 1 other identifier: 240
• Study Type: interventional
• Target: 1,031
• Locations: 12 countries
• Sites: 73

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.

Conditions

Heart Disease

Keywords

ICD; Pacing; Heart Failure

Outcome Measures

Primary Outcomes (1)

• All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure ("HF") Hospitalizations.

  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)

  Enrollment to last visit (up to 45 months post-randomization) or death

Secondary Outcomes (18)

• Occurrence of Worsening Heart Failure-related Adverse Events

  Enrollment to last visit (up to 45 months post-randomization)

• Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time

  Baseline, 12, 24 and 36 month visits

• Heart Chamber Dimensions and Wall Thicknesses

  Baseline, 12, and 24 month visits

• Left Ventricular (LV) Ejection Fraction and Fractional Shortening

  Baseline, 12, and 24 month visits

• Left Ventricular (LV) and Left Atrial (LA) Volumes

  Baseline, 12, and 24 month visits

Study Arms (2)

VVI 40 pacing

ACTIVE COMPARATOR

Backup ventricular pacing (VVI) at 40 beats per minute

Device: ICD (Implantable Cardioverter Defibrillator)

MVP pacing

ACTIVE COMPARATOR

Managed ventricular pacing (MVP) at 60 beats per minute

Device: ICD (Implantable Cardioverter Defibrillator)

Interventions

ICD (Implantable Cardioverter Defibrillator) DEVICE

VVI 40 vs. MVP

Also known as: Intrinsic™, EnTrust™

MVP pacing; VVI 40 pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (73)

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Anchorage, Alaska, United States

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Little Rock, Arkansas, United States

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North Little Rock, Arkansas, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Naples, Florida, United States

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Pensacola, Florida, United States

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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Silver Spring, Maryland, United States

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Takoma Park, Maryland, United States

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Detroit, Michigan, United States

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Lansing, Michigan, United States

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Marquette, Michigan, United States

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Petoskey, Michigan, United States

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Coon Rapids, Minnesota, United States

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Saint Paul, Minnesota, United States

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St Louis, Missouri, United States

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Lebanon, New Hampshire, United States

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Hackensack, New Jersey, United States

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Newark, New Jersey, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Gastonia, North Carolina, United States

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Raleigh, North Carolina, United States

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Mayfield Hts., Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Taylorville, Utah, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Sankt Pölten, Austria

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Aarus, Denmark

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Le Chesnay, France

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Lille, France

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Bad Berka, Germany

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Franfurt Am Main, Germany

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Heidelberg, Germany

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Homburg/Saar, Germany

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Kiel, Germany

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Haifa, Israel

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Milano, Israel

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Tel Aviv, Israel

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Milan, Italy

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Tromsø, Norway

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Valencia, Spain

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Zurich, Switzerland

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London, United Kingdom

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Related Publications (1)

• 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.

  PMID: 20685401 DERIVED

MeSH Terms

Conditions

Heart Diseases; Heart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Results Point of Contact

• Title: MVP Clinical Trial Leader
• Organization: Medtronic, Inc.

medtroniccrmtrials@medtronic.com

Study Officials

• Michael O Sweeney

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 20, 2006
• First Posted: January 24, 2006
• Study Start: October 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 3, 2010
• Results First Posted: August 3, 2010

Record last verified: 2010-07

Locations

IL (3); ES (1); DE (5); CH (1); GB (1); NO (1); IT (1); FR (2); DK (1); US (50); AU (1); CA (6)