Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death
Status:
Terminated
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
St. Michael's Hospital, Toronto Unity Health Toronto
Collaborators:
Institute for Clinical Evaluative Sciences Ontario Ministry of Health and Long Term Care