Managed Ventricular Pacing ("MVP") Trial

This study has been terminated.
(Inability to reach statistical significance toward primary endpoint)
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00281099
First received: January 20, 2006
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Heart Disease
Device: ICD (Implantable Cardioverter Defibrillator)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: MVP Trial (Managed Ventricular Pacing ("MVP") Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute ("VVI 40") Pacing Trial)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Occurrence of Worsening Heart Failure-related Adverse Events [ Time Frame: Enrollment to last visit (up to 45 months post-randomization) ] [ Designated as safety issue: No ]
    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

  • Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time [ Time Frame: Baseline, 12, 24 and 36 month visits ] [ Designated as safety issue: No ]
    NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst.

  • Heart Chamber Dimensions and Wall Thicknesses [ Time Frame: Baseline, 12, and 24 month visits ] [ Designated as safety issue: No ]
    Echocardiogram measures for each endpoint were obtained at multiple time points.

  • Left Ventricular (LV) Ejection Fraction and Fractional Shortening [ Time Frame: Baseline, 12, and 24 month visits ] [ Designated as safety issue: No ]

    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%.


  • Left Ventricular (LV) and Left Atrial (LA) Volumes [ Time Frame: Baseline, 12, and 24 month visits ] [ Designated as safety issue: No ]
    Echocardiogram measures for each endpoint were obtained at multiple time points.

  • Left Ventricular (LV) Sphericity Index [ Time Frame: Baseline, 12, and 24 month visits ] [ Designated as safety issue: No ]

    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.


  • Hemodynamic Velocity Measures [ Time Frame: Baseline, 12, and 24 month visits ] [ Designated as safety issue: No ]
    Echocardiogram measures for each endpoint were obtained at multiple time points.

  • Hemodynamic Deceleration Time [ Time Frame: Baseline, 12, and 24 month visits ] [ Designated as safety issue: No ]
    Echocardiogram measures for each endpoint were obtained at multiple time points.

  • Left Atrial (LA) and Mitral Regurgitation (MR) Areas [ Time Frame: Baseline, 12, and 24 month visits ] [ Designated as safety issue: No ]
    Echocardiogram measures for each endpoint were obtained at multiple time points.

  • Composite Mitral Regurgitation (MR) Severity Score [ Time Frame: Baseline, 12, and 24 month visits ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF

  • 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) ] [ Designated as safety issue: No ]

    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


  • Development of a Pacing Indication During the Study [ Time Frame: Enrollment to last visit (up to 45 months post-randomization) ] [ Designated as safety issue: No ]
    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.

  • Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction [ Time Frame: Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months ] [ Designated as safety issue: No ]
    Whether a subject is on each of a pre-specified set of drugs or classes of drugs.

  • Percent Ventricular Pacing [ Time Frame: Enrollment, 6, 12, 24 and 36 month visits ] [ Designated as safety issue: No ]
    The percentage of a patients' ventricular beats that were paced by the device.

  • Quality of Life ("QOL") Score [ Time Frame: Baseline, 12, 24, and 36 month visits ] [ Designated as safety issue: No ]

    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)


  • All Cause Mortality [ Time Frame: Enrollment to last visit (up to 45 months post-randomization) or death ] [ Designated as safety issue: No ]
    Death from any cause

  • ICD-indicated Patients With Class I Pacemaker Indication. [ Time Frame: Period of time prior to patient consent when considering patient for Implant/Enrollment ] [ Designated as safety issue: No ]
    Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant


Enrollment: 1031
Study Start Date: October 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281099

  Show 73 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Medtronic
Investigators
Principal Investigator: Michael O Sweeney Brigham and Women's Hospital
  More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steve Erickson, Principal Clinical Trial Leader, Medtronic CRDM
ClinicalTrials.gov Identifier: NCT00281099     History of Changes
Other Study ID Numbers: 240
Study First Received: January 20, 2006
Results First Received: June 30, 2009
Last Updated: July 30, 2010
Health Authority: United States: Institutional Review Board
Canada: Health Canada
European Union: European Medicines Agency

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
ICD
Pacing
Heart Failure

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014