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REFINE ICD - INCLUSION/EXCLUSION CRITERIA (Protocol Version 12.1)

Initial inclusion criteria (eligibility for Holter screening)

•    18 - 80 years old at time of consent

•    History of MI ≥ 2 and ≤ 60 months prior to screening based on ESC/ACCF/AHA/WHF criteria
     (both STEMI and NSTEMI subjects are eligible)

•    Appropriate post-MI management including revascularization where indicated

•    No contra-indication for transvenous ICD placement
     (e.g., mechanical tricuspid valve, known vascular access problems, active sepsis, etc.)
 
•    LVEF 36% - 50% measured 40 days to 60 months after a confirmed MI
                              - 
 3 months after coronary angioplasty or coronary bypass surgery
                              -   6 months of the screening visit (+ 30 day window)

•    Proven, necessary or appropriate medications (e.g. beta-blocker, ACE inhibitor/ARB, statin, and anti-platelet)

•    In normal sinus rhythm (ECG documented) within the two weeks prior to the screening Holter

•    Written informed consent

•    Able and willing to complete the screening Holter, including the six-minute hall walk

Additional inclusion criterion (eligibility for randomization)

•    Abnormal HRT & TWA (core lab interpretation) on Holter performed 2 - 60 months after the index MI
     and the specified time after coronary revascularization

•    In normal sinus rhythm (ECG documented) within the two weeks prior to the screening Holter

•    In normal sinus rhythm for 18 hours of the 24 hr screening Holter

Exclusion criteria (randomization or registry)

•    Use of antiarrhythmic drugs

•    Clinical indication for permanent pacemaker or a cardiac resynchronization device
 
•    Clinical indication for an ICD or cardiac resynchronization ICD

•    Prior implantation of a pacemaker, ICD, or Cardiac Resynchronization device

•    Any condition, in the investigator's judgment, that would limit life expectancy to < 12 months

•    Chronic renal failure (hemodialysis or peritoneal dialysis)

•    Active ischemia that is amenable to revascularization if not previously revascularized

•    Participation in another trial that may interfere with the REFINE ICD results

•    Pregnancy

•    Inability to comply with the follow-up schedule
REFINE ICD Clinical Coordinating Centre: TRW Building GE63, 3280 Hospital Drive NW, Calgary, AB, T2N 4Z6, Canada  |  Phone: 1-855-426-6328  |  Fax: (403) 210-8140  |  Contact Us
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