Southfield, Michigan 48075

  • Sudden Death


This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack in the prior 5 years, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.

Study summary:

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



Primary Contact:

Principal Investigator
Derek V Exner, MD, MPH
University of Calgary

Derek V Exner, MD, MPH
Phone: 403-220-3219

Backup Contact:

Caroline (Liong Eng) Tan-Mesiatowsky, MD
Phone: 403-210-7396

Location Contact:

Southfield, Michigan 48075
United States

Cordell Hastings

Site Status: Recruiting

Data Source:

Date Processed: December 03, 2022

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.