CompletedNot Applicable

Resynchronization/Defibrillation for Ambulatory Heart Failure Trial

Australia, Belgium, Canada1,798 participantsStarted 2003-04

Plain-language summary

Congestive heart failure (CHF) is a common health problem that leads to frequent hospitalizations and an increased death rate. In spite of advances in drug therapy, it remains a significant public health problem. Recently, a new therapy has been developed for advanced heart failure patients with a ventricular conduction abnormality. This new therapy, called cardiac resynchronization (CRT), is a device which stimulates the atrium, the right ventricle, and the left ventricle providing synchronization of the contraction of the heart chambers. It is the addition of this therapy to an implantable cardioverter defibrillator (ICD) that will be evaluated in this study. This study will compare whether the implantation of this new therapy device, in combination with an implantable cardioverter defibrillator, will reduce total mortality and hospitalizations for CHF.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * New York Heart Association (NYHA) Class II * Left ventricular ejection fraction (LVEF) less than or equal to 30% by multigated acquisition scan (MUGA)/catheterization OR LVEF less than or equal to 30% and LV end diastolic dimension ≥ 60 mm (by echocardiogram) within 6 months prior to randomization * Intrinsic QRS complex width ≥ 120 ms OR paced QRS measurement ≥ 200 ms * ICD indication for primary or secondary prevention * Optimal heart failure pharmacological therapy * Normal sinus rhythm; OR chronic persistent atrial tachyarrhythmia with resting ventricular heart rate ≤ 60 beats per minute (bpm) and 6 minute hall walk ventricular heart rate of ≤ 90 bpm; OR chronic persistent atrial tachyarrhythmia with resting ventricular heart rate \> 60 bpm and 6 minute hall walk ventricular heart rate of \> 90 bpm and booked for atrioventricular junction ablation. Exclusion Criteria: * Intravenous inotropic agent in the last 4 days * Patients with a life expectancy of less than one year from non-cardiac cause * Expected to undergo cardiac transplantation within one year (status I) * In hospital patients who have acute cardiac or non-cardiac illness that requires intensive care * Uncorrected or uncorrectable primary valvular disease * Restrictive, hypertrophic, or reversible form of cardiomyopathy * Severe primary pulmonary disease such as cor pulmonale * Tricuspid prosthetic valve * Patients with an existing ICD (patients with an existing pacemaker may be include…

What they're measuring

Primary outcome is a composite of all cause total mortality and hospitalization for CHF

Timeframe: Study end

Trial details

NCT IDNCT00251251

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09