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

 -  documented chronic coronary heart disease (prior MI and/or angiographically documented
 CAD), > 40 days post the most recent MI;

 -  LVEF < 40% (by MUGA) and NYHA functional class II or III at time of assessment OR LVEF
 ≤ 35 % (by MUGA) and NYHA functional class I, II or III at time of assessment

 -  Judged to have a reasonable expectation of survival with a good functional status for
 more than 1 year, as well as receiving optimum, guideline recommended therapy for
 coronary artery disease and heart failure (or demonstrated intolerance or
 contraindications to such therapy).

 -  Age ≥ 18 years; no upper age limitation.

 Exclusion Criteria:

 -  Prior cardiac arrest, sustained VT or VF, or unexplained syncope.

 -  Attempted VT / VF induction at electrophysiological study.

 -  Need for a cardiac resynchronization therapy (CRT) device.

 -  Enrollment in another interventional trial.