Resynchronization/Defibrillation for Ambulatory Heart Failure Trial (RAFT)
Heart Failure, Congestive
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Congestive heart failure, Multicentre randomized controlled trial, Defibrillator, Cardiac resynchronization, Sudden death/mortality, Hospitalization, ICD indication, NYHA Class II, LVEF </equal to 30%, QRS >/equal to 120 ms
Eligibility Criteria
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 included if the patients satisfy all other inclusion/exclusion criteria) Coronary revascularization (coronary artery bypass graft surgery [CABG] or percutaneous coronary intervention [PCI]) < 1 month if previously determined LVEF > 30%. Patients with a more recent revascularization can be included if a previously determined LVEF was ≤ 30%. Patients with an acute coronary syndrome including myocardial infarction (MI) can be included if the patients have had a previous MI with LV dysfunction (LVEF ≤ 30%). Patients included in another clinical trial that will affect the objectives of this study History of noncompliance to medical therapy Unable or unwilling to provide informed consent
Sites / Locations
- Royal Adelaide Hospital
- Sir Charles Gairdner Hospital
- University Ziekenhuis
- University of Calgary/Foothill Hospital
- Alberta Heart Institute
- St. Paul's Hospital
- Victoria Cardiac Arrhythmia Trials
- NB Heart Centre Research Initiative
- Memorial Hospital
- Queen Elizabeth II
- Hamilton Health Sciences Centre
- Kingston General Hospital
- St. Mary's Hospital
- London Health Sciences Centre
- Southlake Regional Health Care
- University of Ottawa Heart Institute
- Sunnybrook Hospital
- St. Michael's Hospital
- UHN Toronto General
- Montreal Heart Institute
- CHUM Hopital Notre Dame
- McGill University Health Centre
- Hopital du Sacre Coeur de Montreal
- Laval Hospital
- CHUS Centre Hospitalier Universitaire de Sherbrooke
- Skejby University Hospital
- Zentralklinik
- J.W. Goethe University
- University of Giessen
- Ludwigshafen
- University of Mainz
- Isala Klinieken
- Ege University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1. Optimal Medical therapy plus ICD
2. Optimal Medical Therapy plus CRT/ICD