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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Heart Disease, Congestive Heart Failure, Ventricular Dysfunction, Low Cardiac Output, Sudden Cardiac Death

Intervention / Treatment
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* Drug: Optimized medical therapy
* Device: Implantable Cardioverter Defibrillator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Optimized medical therapy<br>* Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated<br>|
| Other: 2<br> | Device: Implantable Cardioverter Defibrillator<br>* an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly<br>* Other names: ICD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | minimum 1 year follow-up (maximum 6 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications |  | minimum 1 year; maximum 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable Cardioverter Defibrillator, Ejection Fraction, QRS duration