NCT00387803
Completed
Phase 2
VENTAK CHF/CONTAK CD Biventricular Pacing Study
Boston Scientific Corporation1 site in 1 country581 target enrollmentStarted: February 1998Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 581
- Locations
- 1
- Primary Endpoint
- Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia
Overview
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, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic heart failure
- •Left ventricular ejection fraction \<= 35%
- •QRS width \>= 120 ms
- •Indicated for an implantable cardioverter defibrillator
Exclusion Criteria
- •Indicated for a pacemaker
- •Atrial tachyarrhythmias
Outcomes
Primary Outcomes
Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia
Secondary Outcomes
- Peak VO2
- NYHA Class
- Six minute walk distance
- Quality of life
- Echocardiographic measures
Investigators
Study Sites (1)
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