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

Not Applicable

Terminated

• Conditions: Coronary Heart Disease; Congestive Heart Failure; Low Cardiac Output; Ventricular Dysfunction; Sudden Cardiac Death
• Interventions: Drug: Optimized medical therapy; Device: Implantable Cardioverter Defibrillator

• Registration Number: NCT00524862
• Lead Sponsor: Unity Health Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-29
• Study First Submitted QC: 2007-08-31
• Study First Posted: 2007-09-05
• Study Start: 2007-10
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Optimized medical therapy	-
2	Implantable Cardioverter Defibrillator	-

Primary Outcome Measures

Name	Time	Method
All-cause mortality	minimum 1 year follow-up (maximum 6 year)

Secondary Outcome Measures

Name	Time	Method
1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications	minimum 1 year; maximum 6 years

Trial Locations

Locations (10)

Hamilton Health Sciences - Hamilton General; 🇨🇦 Hamilton, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

London Health Sciences - University Campus; 🇨🇦 London, Ontario, Canada

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada

Trillium Health Centre - Mississauga; 🇨🇦 Mississauga, Ontario, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Rouge Valley Health System - Centenary; 🇨🇦 Scarborough, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada