Status:
TERMINATED
Managed Ventricular Pacing ("MVP") Trial
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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)...
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 car...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
1031 Patients enrolled
Trial Details
Trial ID
NCT00281099
Start Date
October 1 2004
End Date
July 1 2008
Last Update
August 3 2010
Active Locations (73)
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1
Anchorage, Alaska, United States
2
Little Rock, Arkansas, United States
3
North Little Rock, Arkansas, United States
4
Brandon, Florida, United States