Status:
COMPLETED
Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure, Congestive
Ventricular Fibrillation
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.
Detailed Description
Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospita...
Eligibility Criteria
Inclusion
- Symptomatic heart failure
- Left ventricular ejection fraction \<= 35%
- QRS width \>= 120 ms
- Indicated for an implantable cardioverter defibrillator
Exclusion
- Indicated for a pacemaker
- Atrial tachyarrhythmias
Key Trial Info
Start Date :
February 1 1998
Trial Type :
INTERVENTIONAL
End Date :
August 1 2001
Estimated Enrollment :
581 Patients enrolled
Trial Details
Trial ID
NCT00387803
Start Date
February 1 1998
End Date
August 1 2001
Last Update
January 25 2007
Active Locations (1)
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1
Multiple locations
Saint Paul, Minnesota, United States, 55112