Heart DiseaseMVPNCT00281099
Managed Ventricular Pacing ("MVP") Trial
A study testing ICD (Implantable Cardioverter Defibrillator) in people with Heart Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 73 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- ICD (Implantable Cardioverter Defibrillator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,031 participants
- Where
- 73 sitesin 12 countries
- Study dates
- Oct 2004to Jul 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
73 sites in 12 countries.
73 sites in 12 countries
United States50 sites
Study site
Allentown, Pennsylvania
Study site
Anchorage, Alaska
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Brandon, Florida
Study site
Charlottesville, Virginia
Study site
Clearwater, Florida
Study site
Columbia, South Carolina
Study site
Coon Rapids, Minnesota
Study site
Des Moines, Iowa
Study site
Detroit, Michigan
Study site
Fort Lauderdale, Florida
Study site
Fort Worth, Texas
Study site
Gastonia, North Carolina
Study site
Hackensack, New Jersey
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Kansas City, Kansas
Study site
Knoxville, Tennessee
Study site
Lansing, Michigan
Study site
Lebanon, New Hampshire
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Louisville, Kentucky
Study site
Marquette, Michigan
Study site
Mayfield Hts., Ohio
Study site
Milwaukee, Wisconsin
Study site
Morgantown, West Virginia
Study site
Naples, Florida
Study site
Nashville, Tennessee
Study site
New Hyde Park, New York
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Newark, New Jersey
Study site
Norfolk, Virginia
Study site
North Little Rock, Arkansas
Study site
Oklahoma City, Oklahoma
Study site
Pensacola, Florida
Study site
Petoskey, Michigan
Study site
Philadelphia, Pennsylvania
Study site
Raleigh, North Carolina
Study site
Richmond, Virginia
Study site
Saint Paul, Minnesota
Study site
Savannah, Georgia
Study site
Silver Spring, Maryland
Study site
St Louis, Missouri
Study site
Takoma Park, Maryland
Study site
Taylorville, Utah
Study site
Tulsa, Oklahoma
Canada6 sites
Study site
Edmonton, Alberta
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Ste-Foy, Quebec
Study site
Vancouver, British Columbia
Study site
Victoria, British Columbia
Germany5 sites
Study site
Bad Berka
Study site
Franfurt Am Main
Study site
Heidelberg
Study site
Homburg/Saar
Study site
Kiel
About this study
Official title: 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.
Read the 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
- Being tested
- ICD (Implantable Cardioverter Defibrillator)
- Keywords
- ICD, Pacing, Heart Failure
- Medical subject headings
- Heart Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD (Implantable Cardioverter Defibrillator)Device
Also called Intrinsic™, EnTrust™
VVI 40 vs. MVP
| Study group | Role | What they receive |
|---|---|---|
| VVI 40 pacing | Active comparator | Backup ventricular pacing (VVI) at 40 beats per minute Receives: Device: ICD (Implantable Cardioverter Defibrillator) |
| MVP pacing | Active comparator | Managed ventricular pacing (MVP) at 60 beats per minute Receives: Device: ICD (Implantable Cardioverter Defibrillator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Enrollment to last visit (up to 45 months post-randomization) or death
Secondary outcomes (18)
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
Measured: Enrollment to last visit (up to 45 months post-randomization)
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.
Measured: Baseline, 12, 24 and 36 month visits
Heart Chamber Dimensions and Wall Thicknesses
Echocardiogram measures for each endpoint were obtained at multiple time points.
Measured: Baseline, 12, and 24 month visits
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%.
Measured: Baseline, 12, and 24 month visits
Left Ventricular (LV) and Left Atrial (LA) Volumes
Echocardiogram measures for each endpoint were obtained at multiple time points.
Measured: Baseline, 12, and 24 month visits
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.
Measured: Baseline, 12, and 24 month visits
Hemodynamic Velocity Measures
Echocardiogram measures for each endpoint were obtained at multiple time points.
Measured: Baseline, 12, and 24 month visits
Hemodynamic Deceleration Time
Echocardiogram measures for each endpoint were obtained at multiple time points.
Measured: Baseline, 12, and 24 month visits
Left Atrial (LA) and Mitral Regurgitation (MR) Areas
Echocardiogram measures for each endpoint were obtained at multiple time points.
Measured: Baseline, 12, and 24 month visits
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.
Measured: Baseline, 12, and 24 month visits
Occurrence of Ventricular Tachycardia ("VT") and Ventricular Fibrillation ("VF") Episodes
Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF
Measured: 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
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
Measured: Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)
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.
Measured: Enrollment to last visit (up to 45 months post-randomization)
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.
Measured: Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months
Percent Ventricular Pacing
The percentage of a patients' ventricular beats that were paced by the device.
Measured: Enrollment, 6, 12, 24 and 36 month visits
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)
Measured: Baseline, 12, 24, and 36 month visits
All Cause Mortality
Death from any cause
Measured: Enrollment to last visit (up to 45 months post-randomization) or death
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
Measured: Period of time prior to patient consent when considering patient for Implant/Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startOct 2004
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Inability to reach statistical significance toward primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,031 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- Michael O Sweeney, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281099
- Sponsor's protocol ID
- 240
- Acronym
- MVP
- Status last verified
- Jul 2010
- First submitted
- 20 Jan 2006
- Last updated
- 3 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20685401
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MVP Trial (Managed Ventricular Pacing ("MVP") Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute ("VVI 40") Pacing Trial)
- ClinicalTrials.gov ID
- NCT00281099
- Acronym / sponsor ID
- MVP / 240
- Conditions
- Heart Disease
- Keywords
- ICD, Pacing, Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to reach statistical significance toward primary endpoint
- Enrolment
- 1,031 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Oct 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 24 Jan 2006 (estimated)
- Results
- Posted 3 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VVI 40 pacing | Active comparator | Device: ICD (Implantable Cardioverter Defibrillator)Backup ventricular pacing (VVI) at 40 beats per minute |
| MVP pacing | Active comparator | Device: ICD (Implantable Cardioverter Defibrillator)Managed ventricular pacing (MVP) at 60 beats per minute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD (Implantable Cardioverter Defibrillator)Also: Intrinsic™, EnTrust™VVI 40 vs. MVP | Device | MVP pacing, VVI 40 pacing |
Primary outcome
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)
18 secondary outcomes
Occurrence of Worsening Heart Failure-related Adverse Events
Time frame: 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
Heart Chamber Dimensions and Wall Thicknesses
Time frame: Baseline, 12, and 24 month visits
Left Ventricular (LV) Ejection Fraction and Fractional Shortening
Time frame: Baseline, 12, and 24 month visits
Left Ventricular (LV) and Left Atrial (LA) Volumes
Time frame: Baseline, 12, and 24 month visits
Left Ventricular (LV) Sphericity Index
Time frame: Baseline, 12, and 24 month visits
Hemodynamic Velocity Measures
Time frame: Baseline, 12, and 24 month visits
Hemodynamic Deceleration Time
Time frame: Baseline, 12, and 24 month visits
Left Atrial (LA) and Mitral Regurgitation (MR) Areas
Time frame: Baseline, 12, and 24 month visits
Composite Mitral Regurgitation (MR) Severity Score
Time frame: 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)
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)
Development of a Pacing Indication During the Study
Time frame: 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
Percent Ventricular Pacing
Time frame: Enrollment, 6, 12, 24 and 36 month visits
Quality of Life ("QOL") Score
Time frame: Baseline, 12, 24, and 36 month visits
All Cause Mortality
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20685401Sweeney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael O Sweeney principal investigator
Brigham and Women's Hospital
73 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD (Implantable Cardioverter Defibrillator) in people with Heart Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 73 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, Canada, Germany, Israel, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00281099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2010; AzTrials last refreshed its copy on 28 Oct 2026.