Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure
The purpose of this study is to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optimal pharmacologic therapy and 1) biventricular pacing therapy alone or 2) biventricular pacing with defibrillation.
Congestive Heart Failure
Device: Cardiac Resynchronization Therapy with & without defibrillator
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure|
- Combination of all-cause mortality and first hospitalization (time to first event), where all-cause mortality is defined as death from all causes.
- Total survival for both the CONTAK CD and CONTAK TR CHFDs when used in conjunction with pharmacologic therapy.
|Study Start Date:||January 2000|
|Estimated Study Completion Date:||December 2002|
Evaluation of new therapies for the treatment of heart failure should address mortality, morbidity, hospitalization, and cardiac symptoms and function when compared to standard pharmacologic therapy. The COMPANION trial is designed to address all of these objectives. This clinical investigation is an open-label, prospective, multi-center, randomized clinical trial. Every patient enrolled in the study is to be prescribed to optimal pharmacologic heart failure therapy, as tolerated, regardless of randomization.