Managed Ventricular Pacing (MVP) Trial - Full Text View

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00281099

Purpose

The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The 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)

MedlinePlus related topics: Heart Diseases Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	MVP Trial (MVP Versus VVI 40 Pacing Trial)

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

Primary Outcome Measures:

This trial will test if MVP (Managed Ventricular Pacing) is equivalent to or superior to VVI 40 pacing with regard to subjects experiencing freedom from all cause mortality and heart failure-related urgent care visits and heart failure hospitalization. [ Time Frame: End of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of MVP to VVI 40 pacing for: Occurrence of clinically important or persistent atrial tachycardia or atrial fibrillation (AT/AF) in subjects with no prior history [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Occurrence of VT and VF episodes [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Development of a Pacing Indication during the study [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Percent of ventricular pacing [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Changes in echocardiogram measurements [ Time Frame: End of trial ] [ Designated as safety issue: No ]
NYHA (New York Heart Association) functional class changes [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Changes in medication affecting heart rate and AV conduction [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Incidence of a Class I pacemaker indication. [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Comparison of MVP to VVI 40 pacing for: occurrence of worsening heart failure-related adverse events [ Time Frame: End of trial ] [ Designated as safety issue: No ]

Enrollment:	1037
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
1: Active Comparator VVI 40 pacing	Device: ICD (Implantable Cardioverter Defibrillator) VVI pacing at 40bpm (beats per minute) and MVP pacing at 60bpm.
2: Active Comparator MVP pacing	Device: ICD (Implantable Cardioverter Defibrillator) VVI pacing at 40bpm (beats per minute) and MVP pacing at 60bpm.

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 signal to the top and bottom chamber 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 MI and an LVEF < or =30%
Ischemic Dilated Cardiomyopathy (IDCM), NYHA Class II or II heart failure, and LVEF < or = 35%
Non-Ischemic Dilated Cardiomyopathy (NIDCM) > 3 months, NYHA Class II or II heart failure, and LVEF < or = 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 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

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

Responsible Party:	Medtronic CRDM ( CRDM Core Clinical )
Study ID Numbers:	240
Study First Received:	January 20, 2006
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00281099
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

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009