Official Title: “Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment

Study Primary Completion Date: April 2011

Intervention(s) in this Clinical Trial

• Drug: Optimized medical therapy
  • Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
• Device: Implantable Cardioverter Defibrillator
  • an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
• Other: 2

Primary Measures

• All-cause mortality
  • Time Frame: minimum 1 year follow-up (maximum 6 year)
    Safety Issue?: No

Secondary Measures

• 1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications
  • Time Frame: minimum 1 year; maximum 6 years
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: St. Michael's Hospital, Toronto

Overall Clinical Trial Officials and Contacts

Paul Dorian, MD Study Chair St. Michael's Hospital, Toronto  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00524862

Study ID Number: 06368

ClinicalTrials.gov Identifier: NCT00524862

Health Authority: Canada: Ministry of Health & Long Term Care, Ontario