REFINE ICD - INCLUSION/EXCLUSION CRITERIA
Initial inclusion criteria
(eligibility for Holter screening)
•
18 - 80 years old at time of consent
•
History of MI ≥ 2 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 at least 40 days after a
confirmed MI ≥ 3 months after coronary angioplasty or
coronary bypass
surgery and within the following time windows:
- LVEF ≤ 7 months of screening visit
if index MI was ≤ 1 year of enrolment
- LVEF ≤ 13 months of screening visit
if index MI was > 1 & < 3 years of enrolment
- LVEF ≤ 25 months of screening visit
if index MI was ≥ 3 years of enrolment
•
Proven, necessary or appropriate medications
(e.g. beta-blocker, ACE inhibitor/ARB, statin, and
anti-platelet)
•
In normal sinus rhythm (ECG documented) ≤ 8 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 at least 2 months after the index MI
and the
specified time after coronary revascularization
• In normal sinus rhythm (ECG documented) within 8 weeks prior to the screening Holter
•
In normal sinus rhythm for ≥ 18 hours of the
24 hr screening Holter as determined by the study Holter
Core Lab |
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 |
|
