Risk Estimation Following Infarction Noninvasive Evaluation - ICD efficacy

Brief Description Of Study

The purpose of the REFINE ICD study is to test whether a device called an implantable cardioverter defibrillator (ICD) can increase the likelihood of survival in patients at risk of heart rhythm irregularities. The Patients between the ages of 18 - 80 years old will be screened to assess heart function and heart rate abmormalities prior to enrollment during the period of 2-14 months after a heart attack. After heart attacks, some people develop dangerous and irregular fast heart rhythms. Why these irregularities occur and why they happen to some people but not to others is only poorly understood. It has been shown that changes in the hearts electrical system may indicate a higher risk of these dangerous irregular heart rhythms. Key eligibility criteria in addition to age and post-MI status include: No contra-indication for transvenous ICD placement Left Ventricular Ejection Fraction between 36% - 50% In normal sinus rhythm (ECG documented) within the two weeks prior to the screening Holter monitor The main study intervention for subjects randomized to ICD therapy is the implanting of any approved Medtronic ICD with wireless telemetry that can be followed via Medtronic CareLink system. Subjects not randomized to ICD implant will receive usual post-MI care.

Clinical Study Identifier: 819124

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