Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death — SMART-ICD  

Congestive Heart Failure Clinical Trial

Official title: Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Output, Low
• Congestive Heart Failure
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Death, Sudden, Cardiac
• Heart Failure
• Low Cardiac Output
• Myocardial Ischemia
• Sudden Cardiac Death
• Ventricular Dysfunction

• NCT number: NCT00524862
• Study type: Interventional
• Source: St. Michael's Hospital, Toronto
• Status: Terminated
• Phase: N/A
• Start date: October 2007
• Completion date: April 2011