Phase
Condition
Blood Clots
Heart Defect
Circulation Disorders
Treatment
Implantable Cardioverter Defibrillator + Usual Care
Usual care
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 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
Study Design
Study Description
Connect with a study center
UZ Leuven - Campus Gasthuisberg
Leuven,
BelgiumSite Not Available
Libin Cardiovascular Institute of Alberta
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
Royal Alexandra Hospital
Edmonton, Alberta T5H 3V9
CanadaSite Not Available
University of Alberta Hospital
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
Fraser Clinical Trials
New Westminster, British Columbia V3L 3W4
CanadaSite Not Available
St. Paul's Hospital/Providence Health Care
Vancouver, British Columbia V6E 1M7
CanadaSite Not Available
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia V8Z 0B9
CanadaSite Not Available
Cardio 1
Winnipeg, Manitoba R3L 1Z5
CanadaSite Not Available
St. Boniface Hospital
Winnipeg, Manitoba R2H 2A6
CanadaSite Not Available
New Brunswick Heart Centre
St. John, New Brunswick E2L 2L4
CanadaSite Not Available
Memorial University of Newfoundland
St Johns, Newfoundland and Labrador A1B 3V6
CanadaSite Not Available
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia B3H 3A7
CanadaSite Not Available
Cambridge Cardiac Care Centre
Cambridge, Ontario N1R 6V6
CanadaSite Not Available
Hamilton Health Sciences Centre
Hamilton, Ontario L8L 2X2
CanadaSite Not Available
Hamilton Health Sciences II
Hamilton, Ontario L8L 2X2
CanadaSite Not Available
University of Western Ontario
London, Ontario N0L 1W0
CanadaSite Not Available
Southlake
Newmarket, Ontario L3Y 2P9
CanadaSite Not Available
Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
CanadaSite Not Available
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3N5
CanadaSite Not Available
Toronto General Hospital
Toronto, Ontario M5G 2C4
CanadaSite Not Available
CHUM
Montreal, Quebec H2W 1T8
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Montreal Heart Institute
Montreal, Quebec H1T 1C8
CanadaSite Not Available
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)
Trois-Rivieres, Quebec G8Z 3R9
CanadaSite Not Available
Prairie Vascular Research Network
Regina, Saskatchewan S4P 0W5
CanadaSite Not Available
Royal University Hospital
Saskatoon, Saskatchewan S7N 0W8
CanadaSite Not Available
Quebec Heart Institute
Laval, G1V 4G5
CanadaSite Not Available
HUCH Helsinki University Central Hospital
Helsinki,
FinlandSite Not Available
University of Oulu
Oulu,
FinlandSite Not Available
CHRU Brest - Hôpital de la Cavale Blanche
Brest,
FranceSite Not Available
Hôpital Guillaume et René Laënnec - CHU de Nantes
Nantes,
FranceSite Not Available
Clinique Pasteur
Toulouse,
FranceSite Not Available
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37099
GermanySite Not Available
Zala Megyei Kórház
Zalaegerszeg,
HungarySite Not Available
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo,
ItalySite Not Available
Policlinico Sant' Orsola - Malpighi
Bologna,
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo
Pavia,
ItalySite Not Available
Oslo Universitetssykehus Rikshospitalet
Oslo,
NorwaySite Not Available
King Saud University
Riyadh,
Saudi ArabiaSite Not Available
Slovak Medical University in Bratislava
Bratislava,
SlovakiaSite Not Available
Unitas Hospital
Centurion,
South AfricaSite Not Available
Hospital General Universitario de Alicante (HGUA)
Alicante, 03010
SpainSite Not Available
Hospital Universitario Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid,
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Universitetssjukhuset Örebro
Örebro, 70185
SwedenSite Not Available
Liverpool Heart and Chest Hospital
Liverpool,
United KingdomSite Not Available
Great Western Hospital NHS Trust
Swindon,
United KingdomSite Not Available
Heart Center Research LLC
Huntsville, Alabama 35801
United StatesSite Not Available
Cardiovascular Consultants Heart Center
Fresno, California 93720
United StatesSite Not Available
Colorado Heart and Vascular
Lakewood, Colorado 80228
United StatesSite Not Available
Hartford Hospital
Hartford, Connecticut 06106
United StatesSite Not Available
Yale University
New Haven, Connecticut 06519
United StatesSite Not Available
Watson Clinic
Lakeland, Florida 33805
United StatesSite Not Available
James A Haley Veterans' Center
Tampa, Florida 33612
United StatesSite Not Available
The Heart Group/Deaconess
Evansville, Indiana 47630
United StatesSite Not Available
Iowa Heart Center
West Des Moines, Iowa 50266
United StatesSite Not Available
Delmarva Heart Foundation
Salisbury, Maryland 21804
United StatesSite Not Available
Beth Israel Deaconess
Boston, Massachusetts 02215
United StatesSite Not Available
Washington University Medical School
Saint Louis, Michigan 63110
United StatesSite Not Available
St. John Providence Hospital
Southfield, Michigan 48075
United StatesSite Not Available
Lester E Cox Medical Center
Springfield, Missouri 65807
United StatesSite Not Available
The Valley Hospital
Ridgewood, New Jersey 07450
United StatesSite Not Available
Associated Cardiovascular Consultants/Lourdes Cardiology Services
Voorhees, New Jersey 08034
United StatesSite Not Available
New York Presbyterian Hospital
New York, New York 10032
United StatesSite Not Available
North Shore LIJ
New York, New York 10029
United StatesSite Not Available
Carolinas Medical Center
Charlotte, North Carolina 28203
United StatesSite Not Available
Northeast Ohio Cardiovascular Specialists
Akron, Ohio 44304
United StatesSite Not Available
Bethesda North Hospital
Cincinnati, Ohio 45242
United StatesSite Not Available
The Lindner Research Center
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Doylestown Cardiology
Doylestown, Pennsylvania 18901
United StatesSite Not Available
Hamot Medical Center
Erie, Pennsylvania 16550
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania 18722
United StatesSite Not Available
South Carolina Heart Center
Columbia, South Carolina 29204
United StatesSite Not Available
Pee Dee Cardiology
Florence, South Carolina 29506
United StatesSite Not Available
Greenville Hospital System
Greenville, South Carolina 29605
United StatesSite Not Available
Spartanburg Regional Healthcare System
Spartanburg, South Carolina 29303
United StatesSite Not Available
St. Thomas Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Amarillo Heart Group
Amarillo, Texas 79106
United StatesSite Not Available
Scott & White Healthcare
Temple, Texas 76508
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
Centra Medical Group
Lynchburg, Virginia 24510
United StatesSite Not Available
Heart Clinics Northwest
Spokane, Washington 99204
United StatesSite Not Available
Aurora St. Luke's Medical Center/Aurora Cardiovascular Services
Milwaukee, Wisconsin 53215
United StatesSite Not Available
Wheaton Franciscan Healthcare
Milwaukee, Wisconsin 53210
United StatesSite Not Available
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