Implantable Defibrillator for Heart Attack
(REFINE-ICD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if an implantable defibrillator (a device that helps control irregular heartbeats) can improve survival chances for people who have had a heart attack. The study compares outcomes for patients receiving the device plus usual care versus those receiving only usual care. Candidates include individuals who had a heart attack at least two months ago and show abnormal results from a 24-hour heart monitor. The trial seeks participants with low normal heart function who are on necessary heart medications and have not had certain heart devices implanted before. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking heart treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those using antiarrhythmic drugs. You should discuss your specific medications with the trial team.
What prior data suggests that this implantable defibrillator is safe for heart attack patients?
Research has shown that implantable cardioverter defibrillators (ICDs) are generally well-tolerated by individuals who have experienced a heart attack. These devices help prevent sudden death from heart problems, particularly in those with weakened heart function.
One study found that people with ICDs lived longer compared to those without them. However, some risks exist. About 10% of individuals with ICDs experienced serious health issues, and around 30% had episodes of dangerous heart rhythms. While significant, these events can be managed for many individuals.
Overall, ICDs serve as a safety net against life-threatening heart issues, making them a valuable option for some heart attack survivors.12345Why do researchers think this study treatment might be promising?
Researchers are excited about implantable cardioverter defibrillators (ICDs) for heart attack patients because these devices offer a unique way to prevent sudden cardiac arrest, a risk that remains high even after a heart attack. Unlike standard treatments that primarily involve medications and lifestyle changes to manage heart health, ICDs actively monitor heart rhythms and can automatically deliver life-saving electric shocks if a dangerous arrhythmia is detected. This proactive mechanism provides an immediate response to life-threatening situations, potentially reducing the risk of sudden death and offering peace of mind to patients and their families.
What evidence suggests that an implantable defibrillator is effective for heart attack patients?
Research has shown that implantable cardioverter defibrillators (ICDs), which participants in this trial may receive, can help certain heart patients live longer. For those without ischemic heart disease (IHD), ICDs reduced the risk of death by 24%. In patients with ischemic cardiomyopathy, a type of heart disease, ICDs also lowered the risk of death. Additionally, ICDs reduced sudden cardiac deaths in heart attack patients compared to those who didn't receive an ICD, with a hazard ratio of 0.55. These findings suggest that ICDs might effectively help people survive after a heart attack, especially those with specific heart conditions.678910
Who Is on the Research Team?
Derek V Exner, MD, MPH
Principal Investigator
University of Calgary
Are You a Good Fit for This Trial?
This trial is for people who've had a heart attack, show abnormal results from a day-long heart monitor test, and have low but normal heart function. The specific eligibility will be determined by the site investigators.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an implantable cardioverter defibrillator (ICD) and usual post-MI care
Follow-up
Participants are monitored for survival and heart function after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Implantable Cardioverter Defibrillator
Trial Overview
The study is testing if an implantable defibrillator can help patients live longer after having a heart attack compared to usual care without the device.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Implantable Cardioverter Defibrillator + Usual Care
Usual post-MI care
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Cardiac Arrhythmia Network of Canada
Collaborator
Accelerating Clinical Trials Consortium
Collaborator
Accelerating Clinical Trials Consortium
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Alberta Innovation and Science
Collaborator
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc
GE Healthcare
Industry Sponsor
Fotis Vlachos
GE Healthcare
Chief Marketing Officer since 2024
PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania
Peter J. Arduini
GE Healthcare
Chief Executive Officer since 2022
MBA from Northwestern University, BSc in Marketing from Susquehanna University
Citations
Implantable cardioverter defibrillators did not improve ...
Almost half of deaths (47.4%) were adjudicated as non-cardiac deaths. Cardiac mortality was not reduced in the ICD group vs. controls (8.8% vs.
Implantable cardioverter defibrillators for primary prevention of ...
In patients without IHD, ICD therapy reduced mortality by 24% (HR 0.76, 95% CI 0.64 to 0.90, P = 0.001). In patients with IHD, ICD implantation (at a dedicated ...
Efficacy and safety of implantable cardioverter-defibrillator ...
The purpose of this study was to determine the efficacy and safety of ICD implantation in patients 70 years and older.
Myocardial scar burden predicts survival benefit with ...
Implantable cardioverter defibrillators (ICDs) have been shown to reduce mortality in patients with ischaemic cardiomyopathy (ICM) and significant LV systolic ...
Defibrillator Implantation Early after Myocardial Infarction
There were fewer sudden cardiac deaths in the ICD group than in the control group (27 vs. 60; hazard ratio, 0.55; 95% CI, 0.31 to 1.00; P=0.049) ...
Optimal Timing of Cardioverter-Defibrillator Implantation in ...
Implantable cardiac defibrillator (ICD) placement is not indicated in the first 40 days after an AMI; this timing is aleatory.
HRS/ACC/AHA Expert Consensus Statement on the Use of ...
After a mean follow-up of 30 months, there was no mortality benefit associated with the ICD implant (HR: 1.08; 95% CI: 0.76–1.55; P=.66). In the ...
Clinical and arrhythmic outcomes after implantation of a ...
Total mortality was 10.4%. Close to one-third (30%) of patients experienced episodes of sustained ventricular arrhythmia. One-quarter (23%) ...
Comparative analysis of implantable cardioverter ...
A comprehensive analysis of all patients revealed that individuals with ICD implantation exhibited significantly improved survival outcomes (HR ...
Improve the Prevention of Sudden Cardiac Arrest in Patients ...
COMPETENCY IN MEDICAL KNOWLEDGE: Post-MI patients are at an increased risk for SCD. ICDs can reduce mortality in post-MI patients with reduced ...
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