Back to resultsManaged Ventricular Pacing ("MVP") Trial (MVP)
Primary Purpose
Heart Disease
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ICD (Implantable Cardioverter Defibrillator)
Sponsored by
About this trial
This is an interventional prevention trial for Heart Disease focused on measuring ICD, Pacing, Heart Failure
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
VVI 40 pacing
MVP pacing
Arm Description
Backup ventricular pacing (VVI) at 40 beats per minute
Managed ventricular pacing (MVP) at 60 beats per minute
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Occurrence of Worsening Heart Failure-related Adverse Events
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
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
Echocardiogram measures for each endpoint were obtained at multiple time points.
Left Ventricular (LV) Ejection Fraction and Fractional Shortening
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
Echocardiogram measures for each endpoint were obtained at multiple time points.
Left Ventricular (LV) Sphericity Index
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
Echocardiogram measures for each endpoint were obtained at multiple time points.
Hemodynamic Deceleration Time
Echocardiogram measures for each endpoint were obtained at multiple time points.
Left Atrial (LA) and Mitral Regurgitation (MR) Areas
Echocardiogram measures for each endpoint were obtained at multiple time points.
Composite Mitral Regurgitation (MR) Severity Score
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
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
Persistent AF was defined as any of the following:
2 consecutive visits in which the patient presents with AF
7 consecutive days of at least 22 hours per day of AT/AF
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
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
Whether a subject is on each of a pre-specified set of drugs or classes of drugs.
Percent Ventricular Pacing
The percentage of a patients' ventricular beats that were paced by the device.
Quality of Life ("QOL") Score
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
Death from any cause
ICD-indicated Patients With Class I Pacemaker Indication.
Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant
Full Information
NCT ID
NCT00281099
First Posted
January 20, 2006
Last Updated
July 30, 2010
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00281099
Brief Title
Managed Ventricular Pacing ("MVP") Trial
Acronym
MVP
Official Title
MVP Trial (Managed Ventricular Pacing ("MVP") Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute ("VVI 40") Pacing Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Why Stopped
Inability to reach statistical significance toward primary endpoint
Study Start Date
October 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
ICD, Pacing, Heart Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1031 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VVI 40 pacing
Arm Type
Active Comparator
Arm Description
Backup ventricular pacing (VVI) at 40 beats per minute
Arm Title
MVP pacing
Arm Type
Active Comparator
Arm Description
Managed ventricular pacing (MVP) at 60 beats per minute
Intervention Type
Device
Intervention Name(s)
ICD (Implantable Cardioverter Defibrillator)
Other Intervention Name(s)
Intrinsic™, EnTrust™
Intervention Description
VVI 40 vs. MVP
Primary Outcome Measure Information:
Title
All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure ("HF") Hospitalizations.
Description
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)
Time Frame
Enrollment to last visit (up to 45 months post-randomization) or death
Secondary Outcome Measure Information:
Title
Occurrence of Worsening Heart Failure-related Adverse Events
Description
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
Time Frame
Enrollment to last visit (up to 45 months post-randomization)
Title
Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time
Description
NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst.
Time Frame
Baseline, 12, 24 and 36 month visits
Title
Heart Chamber Dimensions and Wall Thicknesses
Description
Echocardiogram measures for each endpoint were obtained at multiple time points.
Time Frame
Baseline, 12, and 24 month visits
Title
Left Ventricular (LV) Ejection Fraction and Fractional Shortening
Description
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%.
Time Frame
Baseline, 12, and 24 month visits
Title
Left Ventricular (LV) and Left Atrial (LA) Volumes
Description
Echocardiogram measures for each endpoint were obtained at multiple time points.
Time Frame
Baseline, 12, and 24 month visits
Title
Left Ventricular (LV) Sphericity Index
Description
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.
Time Frame
Baseline, 12, and 24 month visits
Title
Hemodynamic Velocity Measures
Description
Echocardiogram measures for each endpoint were obtained at multiple time points.
Time Frame
Baseline, 12, and 24 month visits
Title
Hemodynamic Deceleration Time
Description
Echocardiogram measures for each endpoint were obtained at multiple time points.
Time Frame
Baseline, 12, and 24 month visits
Title
Left Atrial (LA) and Mitral Regurgitation (MR) Areas
Description
Echocardiogram measures for each endpoint were obtained at multiple time points.
Time Frame
Baseline, 12, and 24 month visits
Title
Composite Mitral Regurgitation (MR) Severity Score
Description
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.
Time Frame
Baseline, 12, and 24 month visits
Title
Occurrence of Ventricular Tachycardia ("VT") and Ventricular Fibrillation ("VF") Episodes
Description
Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF
Time Frame
Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)
Title
Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History
Description
Persistent AF was defined as any of the following:
2 consecutive visits in which the patient presents with AF
7 consecutive days of at least 22 hours per day of AT/AF
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
Time Frame
Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)
Title
Development of a Pacing Indication During the Study
Description
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.
Time Frame
Enrollment to last visit (up to 45 months post-randomization)
Title
Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction
Description
Whether a subject is on each of a pre-specified set of drugs or classes of drugs.
Time Frame
Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months
Title
Percent Ventricular Pacing
Description
The percentage of a patients' ventricular beats that were paced by the device.
Time Frame
Enrollment, 6, 12, 24 and 36 month visits
Title
Quality of Life ("QOL") Score
Description
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)
Time Frame
Baseline, 12, 24, and 36 month visits
Title
All Cause Mortality
Description
Death from any cause
Time Frame
Enrollment to last visit (up to 45 months post-randomization) or death
Title
ICD-indicated Patients With Class I Pacemaker Indication.
Description
Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant
Time Frame
Period of time prior to patient consent when considering patient for Implant/Enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael O Sweeney
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
City
Anchorage
State/Province
Alaska
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
North Little Rock
State/Province
Arkansas
Country
United States
City
Brandon
State/Province
Florida
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Fort Lauderdale
State/Province
Florida
Country
United States
City
Naples
State/Province
Florida
Country
United States
City
Pensacola
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Savannah
State/Province
Georgia
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Des Moines
State/Province
Iowa
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Silver Spring
State/Province
Maryland
Country
United States
City
Takoma Park
State/Province
Maryland
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Lansing
State/Province
Michigan
Country
United States
City
Marquette
State/Province
Michigan
Country
United States
City
Petoskey
State/Province
Michigan
Country
United States
City
Coon Rapids
State/Province
Minnesota
Country
United States
City
St. Paul
State/Province
Minnesota
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Newark
State/Province
New Jersey
Country
United States
City
New Hyde Park
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Gastonia
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Mayfield Hts.
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Taylorville
State/Province
Utah
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
St. Pölten
Country
Austria
City
Edmonton
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Victoria
State/Province
British Columbia
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Ste-Foy
State/Province
Quebec
Country
Canada
City
Aarus
Country
Denmark
City
Le Chesnay
Country
France
City
Lille
Country
France
City
Bad Berka
Country
Germany
City
Franfurt am Main
Country
Germany
City
Heidelberg
Country
Germany
City
Homburg/Saar
Country
Germany
City
Kiel
Country
Germany
City
Haifa
Country
Israel
City
Milano
Country
Israel
City
Tel Aviv
Country
Israel
City
Milan
Country
Italy
City
Tromso
Country
Norway
City
Valencia
Country
Spain
City
Zürich
Country
Switzerland
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20685401
Citation
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.
Results Reference
derived
Learn more about this trial
Managed Ventricular Pacing ("MVP") Trial
We'll reach out to this number within 24 hrs