Clinical trial NCT00281099: Managed Ventricular Pacing ("MVP") Trial
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
Overall status: TERMINATED
Phase: NA
Conditions: Heart Disease
Keywords: ICD
Pacing
Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-01-24
Enrollment: 1031
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure ("HF") Hospitalizations.
timeFrame: Enrollment to last visit (up to 45 months post-randomization) or death
Secondary outcomes:
measure: Occurrence of Worsening Heart Failure-related Adverse Events
timeFrame: Enrollment to last visit (up to 45 months post-randomization)
measure: Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time
timeFrame: Baseline, 12, 24 and 36 month visits
measure: Heart Chamber Dimensions and Wall Thicknesses
timeFrame: Baseline, 12, and 24 month visits
measure: Left Ventricular (LV) Ejection Fraction and Fractional Shortening
timeFrame: Baseline, 12, and 24 month visits
measure: Left Ventricular (LV) and Left Atrial (LA) Volumes
timeFrame: Baseline, 12, and 24 month visits
measure: Left Ventricular (LV) Sphericity Index
timeFrame: Baseline, 12, and 24 month visits
measure: Hemodynamic Velocity Measures
timeFrame: Baseline, 12, and 24 month visits
measure: Hemodynamic Deceleration Time
timeFrame: Baseline, 12, and 24 month visits
measure: Left Atrial (LA) and Mitral Regurgitation (MR) Areas
timeFrame: Baseline, 12, and 24 month visits
measure: Composite Mitral Regurgitation (MR) Severity Score
timeFrame: Baseline, 12, and 24 month visits
measure: Occurrence of Ventricular Tachycardia ("VT") and Ventricular Fibrillation ("VF") Episodes
timeFrame: Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)
measure: Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History
timeFrame: Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)
measure: Development of a Pacing Indication During the Study
timeFrame: Enrollment to last visit (up to 45 months post-randomization)
measure: Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction
timeFrame: Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months
measure: Percent Ventricular Pacing
timeFrame: Enrollment, 6, 12, 24 and 36 month visits
measure: Quality of Life ("QOL") Score
timeFrame: Baseline, 12, 24, and 36 month visits
measure: All Cause Mortality
timeFrame: Enrollment to last visit (up to 45 months post-randomization) or death
measure: ICD-indicated Patients With Class I Pacemaker Indication.
timeFrame: Period of time prior to patient consent when considering patient for Implant/Enrollment
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Little Rock
country: United States
state: Arkansas
city: North Little Rock
country: United States
state: Arkansas
city: Brandon
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Petoskey
country: United States
state: Michigan
city: Coon Rapids
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Hackensack
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Gastonia
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Mayfield Hts.
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Taylorville
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: St. Pölten
country: Austria
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
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
Study officials:
affiliation: Brigham and Women's Hospital
name: Michael O Sweeney
role: PRINCIPAL_INVESTIGATOR
References:
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.