Managed Ventricular Pacing ("MVP") Trial (MVP)

July 30, 2010 updated by: Medtronic Cardiac Rhythm and Heart Failure

MVP Trial (Managed Ventricular Pacing ("MVP") Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute ("VVI 40") Pacing Trial)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1031

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: VVI 40 pacing
Backup ventricular pacing (VVI) at 40 beats per minute
Device: ICD (Implantable Cardioverter Defibrillator)
VVI 40 vs. MVP
Other Names:
  • Intrinsic™
  • EnTrust™
Active Comparator: MVP pacing
Managed ventricular pacing (MVP) at 60 beats per minute
Device: ICD (Implantable Cardioverter Defibrillator)
VVI 40 vs. MVP
Other Names:
  • Intrinsic™
  • EnTrust™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure ("HF") Hospitalizations.
Time Frame: Enrollment to last visit (up to 45 months post-randomization) or death
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Worsening Heart Failure-related Adverse Events
Time Frame: Enrollment to last visit (up to 45 months post-randomization)
HF event meeting primary endpoint definition, or adverse events associated with, but not limited to, any of the following: symptoms or physical signs compatible with worsening HF, laboratory evidence of HF, any modification of oral heart failure therapy
Enrollment to last visit (up to 45 months post-randomization)
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time
Time Frame: Baseline, 12, 24 and 36 month visits
NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst.
Baseline, 12, 24 and 36 month visits
Heart Chamber Dimensions and Wall Thicknesses
Time Frame: Baseline, 12, and 24 month visits
Echocardiogram measures for each endpoint were obtained at multiple time points.
Baseline, 12, and 24 month visits
Left Ventricular (LV) Ejection Fraction and Fractional Shortening
Time Frame: Baseline, 12, and 24 month visits

Echocardiogram measures for each endpoint were obtained at multiple time points.

LV Ejection Fraction is the percentage of a patient's blood moved out of the left venricle when the heart pumps. The measure is recorded as a percentage(0-100%) and the normal range is 50-85%.

LV Fractional Shortening is the percent change in a patient's LV internal dimensions between systole (when the ventricles contract and expel blood) and diastole (when the ventricles expand and receive blood). The measure is recorded as a percentage(0-100%) and the normal range is 30-45%.
Baseline, 12, and 24 month visits
Left Ventricular (LV) and Left Atrial (LA) Volumes
Time Frame: Baseline, 12, and 24 month visits
Echocardiogram measures for each endpoint were obtained at multiple time points.
Baseline, 12, and 24 month visits
Left Ventricular (LV) Sphericity Index
Time Frame: Baseline, 12, and 24 month visits

Echocardiogram measures for each endpoint were obtained at multiple time points.

LV Sphericity Index is a ratio of LV long axis dimension to the LV short axis dimension. Healthy hearts have an elliptical LV cross-sectional shape. A value of 1 denotes a circular or more globular shape, while larger values denote healthier hearts with more elliptical cross sections. Literature has shown that when the ratio used is short axis/long axis, normal hearts have a median LV sphericity index of 0.56, with a range of (0.51-0.60). This translates to median=1.79,range=(1.67,1.96) for long/short axis.
Baseline, 12, and 24 month visits
Hemodynamic Velocity Measures
Time Frame: Baseline, 12, and 24 month visits
Echocardiogram measures for each endpoint were obtained at multiple time points.
Baseline, 12, and 24 month visits
Hemodynamic Deceleration Time
Time Frame: Baseline, 12, and 24 month visits
Echocardiogram measures for each endpoint were obtained at multiple time points.
Baseline, 12, and 24 month visits
Left Atrial (LA) and Mitral Regurgitation (MR) Areas
Time Frame: Baseline, 12, and 24 month visits
Echocardiogram measures for each endpoint were obtained at multiple time points.
Baseline, 12, and 24 month visits
Composite Mitral Regurgitation (MR) Severity Score
Time Frame: Baseline, 12, and 24 month visits
Echocardiogram measures for this endpoint were obtained at multiple time points. Composite MR Severity was measured on a scale of "None to Trivial" to "Grade IV", with Grade IV being the worst possible score and "None to Trivial" being the best possible score.
Baseline, 12, and 24 month visits
Occurrence of Ventricular Tachycardia ("VT") and Ventricular Fibrillation ("VF") Episodes
Time Frame: Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)
Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF
Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)
Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History
Time Frame: Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)

Persistent AF was defined as any of the following:

  1. 2 consecutive visits in which the patient presents with AF
  2. 7 consecutive days of at least 22 hours per day of AT/AF
  3. A cardioversion prior to 7 consecutive days of at least 22 hours per day of AT/AF

Clinically Important AF was defined as more than 20 hours of AT/AF in a single day
Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)
Development of a Pacing Indication During the Study
Time Frame: Enrollment to last visit (up to 45 months post-randomization)
Physician identification of a Class I Pacing Indication. A Class I Pacing Indication implies that the benefit of pacing the heart far exceeds the risk, and that the procedure to implant the pacing device should be performed. For this indication there is general agreement that pacing the heart is beneficial, useful, and effective.
Enrollment to last visit (up to 45 months post-randomization)
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction
Time Frame: Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months
Whether a subject is on each of a pre-specified set of drugs or classes of drugs.
Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months
Percent Ventricular Pacing
Time Frame: Enrollment, 6, 12, 24 and 36 month visits
The percentage of a patients' ventricular beats that were paced by the device.
Enrollment, 6, 12, 24 and 36 month visits
Quality of Life ("QOL") Score
Time Frame: Baseline, 12, 24, and 36 month visits

Minnesota Living with Heart Failure Questionnaire ("MLWHFQ") and Kansas City Cardiomyopathy Questionnaire ("KCCQ") Quality of Life("QOL") Scores. For KCCQ, positive values mean improved QOL compared to baseline. For MLWHFQ, negative values mean improved QOL compared to baseline.

Scales: KCCQ 0-100 (0=worst, 100 best); MLWHFQ 0-105 (105=worst, 0=best)
Baseline, 12, 24, and 36 month visits
All Cause Mortality
Time Frame: Enrollment to last visit (up to 45 months post-randomization) or death
Death from any cause
Enrollment to last visit (up to 45 months post-randomization) or death
ICD-indicated Patients With Class I Pacemaker Indication.
Time Frame: Period of time prior to patient consent when considering patient for Implant/Enrollment
Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant
Period of time prior to patient consent when considering patient for Implant/Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

  • Principal Investigator: Michael O Sweeney, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

January 20, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimate)

January 24, 2006

Study Record Updates

Last Update Posted (Estimate)

August 3, 2010

Last Update Submitted That Met QC Criteria

July 30, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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