Status:
COMPLETED
FAST (Fluid Accumulation Status Trial)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Congestive Heart Failure
Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using very low electrical pul...
Eligibility Criteria
Inclusion
- Subjects with one of the following implantable cardioverter defibrillators (ICDs): InSync Marquis™, InSync II Marquis™, Marquis® DR, or InSync III Marquis™.
- Subjects with an ICD placed in the upper part of the left or right side of their chest.
- Subjects with a lead (flexible wire that sends electrical signals from the ICD directly to the heart tissue) that is inserted through a vein and placed in the right ventricle (RV) of the heart (a transvenous RV lead).
- Subjects who underwent the ICD implant procedure, or any readjusting of the ICD, 30 days or more prior to enrolling in the study.
Exclusion
- Subjects who are already enrolled in another clinical study.
- Subjects who have received a heart transplant.
- Subjects who are unable or unwilling to follow the study schedule of visits.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00289276
Start Date
November 1 2003
Last Update
October 13 2010
Active Locations (16)
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1
Alaska Cardiovascular Research Foundation
Anchorage, Alaska, United States, 99508
2
Palm Beach Heart Institute
Atlantis, Florida, United States, 33462
3
Fort Wayne Cardiology
Fort Wayne, Indiana, United States, 46805
4
Genesis Medical Center
Davenport, Iowa, United States, 52803