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NCT00673842CompletedPhase 3

Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction

Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy

Source: ClinicalTrials.gov · Last updated 30 May 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
700 (estimated)
First submitted
29 Apr 2008
Start date
18 Apr 2011
Primary completion date
31 Oct 2024
Lead sponsor
University of Calgary
NCT number
NCT00673842

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 700
  • From 18 Apr 2011 to the primary completion date, 31 Oct 2024
  • 78 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of antiarrhythmic drugs
  • Prior implantation of a pacemaker, ICD, or Cardiac Resynchronization device
  • Active ischemia that is amenable to revascularization if not previously revascularized

Other illness

  • Clinical indication for permanent pacemaker or a cardiac resynchronization device
  • Clinical indication for an ICD or cardiac resynchronization ICD
  • Any condition, in the investigator's judgment, that would limit life expectancy to \< 12 months
  • Chronic renal failure (hemodialysis or peritoneal dialysis)

Other

  • Participation in another trial that may interfere with the REFINE ICD results.
  • Pregnancy
  • Inability to comply with the follow-up schedule

Criteria the registry did not label

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (78)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Uz Leuven Campus Gasthuisberg
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LeuvenBelgiumUnknown status
Libin Cardiovascular Institute of Alberta
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CalgaryCanadaUnknown status
Cambridge Cardiac Care Centre
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CambridgeCanadaUnknown status
Royal Alexandra Hospital
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EdmontonCanadaUnknown status
University of Alberta Hospital
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EdmontonCanadaUnknown status
Queen Elizabeth II Health Sciences Center
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HalifaxCanadaUnknown status
Hamilton Health Sciences Centre
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HamiltonCanadaUnknown status
Quebec Heart Institute
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LavalCanadaUnknown status
University of Western Ontario
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LondonCanadaUnknown status
CHUM
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MontrealCanadaUnknown status
Montreal Heart Institute
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MontrealCanadaUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
Southlake
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NewmarketCanadaUnknown status
Fraser Clinical Trials
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New WestminsterCanadaUnknown status
Ottawa Heart Institute
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OttawaCanadaUnknown status
Prairie Vascular Research Network
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ReginaCanadaUnknown status
New Brunswick Heart Centre
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Saint JohnCanadaUnknown status
Royal University Hospital
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SaskatoonCanadaUnknown status
Centre hospitalier universitaire de Sherbrooke (CHUS)
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SherbrookeCanadaUnknown status
Sunnybrook Health Sciences Centre
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TorontoCanadaUnknown status
Toronto General Hospital
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TorontoCanadaUnknown status
St. Michael's Hospital
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TorontoCanadaUnknown status
Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)
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Trois-RivièresCanadaUnknown status
St. Paul's Hospital - Providence Health Care
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VancouverCanadaUnknown status
Vancouver General Hospital
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VancouverCanadaUnknown status
Victoria Cardiac Arrhythmia Trials
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VictoriaCanadaUnknown status
Cardio 1
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WinnipegCanadaUnknown status
St. Boniface Hospital
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WinnipegCanadaUnknown status
Universitätsmedizin Göttingen - Georg-August-Universität
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GöttingenGermanyUnknown status
Hospital General Universitario de Alicante (HGUA)
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AlicanteSpainUnknown status
Hospital Universitario Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
HUCH Helsinki University Central Hospital
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HelsinkiFinlandUnknown status
University Of Oulu
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OuluFinlandUnknown status
CHRU Brest - Hôpital de la Cavale Blanche
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BrestFranceUnknown status
Hôpital Guillaume et René Laënnec - CHU de Nantes
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NantesFranceUnknown status
Clinique Pasteur
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ToulouseFranceUnknown status
Liverpool Heart and Chest Hospital
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LiverpoolUnited KingdomUnknown status
Great Western Hospital NHS Trust
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SwindonUnited KingdomUnknown status
Zala Megyei Kórház
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ZalaegerszegHungaryUnknown status
Azienda Ospedaliera Papa Giovanni XXIII
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BergamoItalyUnknown status
Policlinico Sant'Orsola-Malpighi
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BolognaItalyUnknown status
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyUnknown status
Oslo Universitetssykehus Rikshospitalet
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OsloNorwayUnknown status
King Saud University
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RiyadhSaudi ArabiaUnknown status
Universitetssjukhuset Örebro
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ÖrebroSwedenUnknown status
Slovak Medical University in Bratislava
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BratislavaSlovakiaUnknown status
Northeast Ohio Cardiovascular Specialists
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AkronUnited StatesUnknown status
Amarillo Heart Group
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AmarilloUnited StatesUnknown status
Beth Israel Deaconess
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BostonUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
Bethesda North Hospital
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CincinnatiUnited StatesUnknown status
The Lindner Research Center
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CincinnatiUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
The Ohio State University
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ColumbusUnited StatesUnknown status
Doylestown Cardiology
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DoylestownUnited StatesUnknown status
The Heart Group/Deaconess
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EvansvilleUnited StatesUnknown status
Greenville Hospital System
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GreenvilleUnited StatesUnknown status
Heart Center Research, LLC
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HuntsvilleUnited StatesUnknown status
Colorado Heart and Vascular
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LakewoodUnited StatesUnknown status
Centra Medical Group
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LynchburgUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
St. Thomas Research Institute
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NashvilleUnited StatesUnknown status
New York - Presbyterian Hospital
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New YorkUnited StatesUnknown status
North Shore LIJ
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New YorkUnited StatesUnknown status
University of Pittsburgh Medical Center UPMC Presbyterian
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PittsburghUnited StatesUnknown status
The Valley Hospital
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RidgewoodUnited StatesUnknown status
Washington University Medical School
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Saint LouisUnited StatesUnknown status
Delmarva Heart Foundation
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SalisburyUnited StatesUnknown status
St. John Providence Hospital
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SouthfieldUnited StatesUnknown status
Heart Clinics Northwest
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SpokaneUnited StatesUnknown status
Lester E Cox Medical Center
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SpringfieldUnited StatesUnknown status
James A Haley Veterans' Center
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TampaUnited StatesUnknown status
Associated Cardiovascular Consultants/Lourdes Cardiology Services
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Voorhees TownshipUnited StatesUnknown status
Iowa Heart Center
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West Des MoinesUnited StatesUnknown status
Geisinger Wyoming Valley Medical Center
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Wilkes-BarreUnited StatesUnknown status
Unitas Hospital
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CenturionSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.