Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure
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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.
Condition or disease
Congestive Heart Failure
Device: Cardiac Resynchronization Therapy with & without defibrillator
Phase 2Phase 3
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Moderate or severe heart failure, defined as symptomatic heart failure for at least six months with NYHA Class III or IV symptoms at the time of enrollment, AND at least one of the following events in the previous 12 months:
Hospitalization for heart failure management
Outpatient visit in which intravenous (IV) inotropes or vasoactive infusion were administered continuously for at least 4 hours
Emergency room visit of at least twelve hours duration in which IV heart failure medications were administered (including diuretics)
QRS > or = 120 ms and PR interval > 150 ms from any two leads of a 12-lead ECG
Left ventricular ejection fraction < or = 35%
Left ventricular end diastolic dimension > or = 60 mm (required only if LVEF measured by echo) or > 3.0 cm/m2 [The cm/m2 is calculated by LVEDD (in cm) divided by BSA (body surface area)].
Age > or = 18 years
Optimal pharmacologic therapy for heart failure
Unable or unwilling to undergo device implant and follow-up testing
Meet the general indications for an implantable cardioverter defibrillator
Meet the general indications for antibradycardia pacing
Expected to receive a heart transplant in the next six months