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Low Cardiac Output clinical trials

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NCT ID: NCT00524862 Terminated - Clinical trials for Congestive Heart Failure

Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death

SMART-ICD
Start date: October 2007
Phase: N/A
Study type: Interventional

Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF < 40%. Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF < 30% (Class I recommendation). There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy. The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD.