Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction

The REFINE ICD trial will assess whether prophylactic ICD therapy, guided by non-invasive
risk assessment tools, reduces mortality in MI survivors with better-preserved LV function.

Site investigators are responsible for screening. Subjects must meet all inclusion
criteria. Subjects with any exclusion criteria will be excluded.

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 2 to 60 months after a confirmed MI, > / = 3 months after
coronary angioplasty or coronary bypass surgery and < / = 6 months of the screening
visit

- 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 to 60 months after
the index MI and the specified time after coronary revascularization

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