Implantable Defibrillator for Heart Attack

(REFINE-ICD Trial)

No longer recruiting at 80 trial locations

Overseen By Caroline Tan-Mesiatowsky, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Calgary

Must be taking: Beta-blockers, ACE inhibitors

Must not be taking: Antiarrhythmic drugs

Disqualifiers: Pacemaker, Chronic renal failure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

In normal sinus rhythm (ECG documented) ≤ 8 weeks prior to the screening Holter

Written informed consent

I can do a heart monitoring test and a six-minute walk test.

Exclusion Criteria

Inability to comply with the follow-up schedule

Clinical indication for an ICD or cardiac resynchronization ICD

Prior implantation of a pacemaker, ICD, or Cardiac Resynchronization device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an implantable cardioverter defibrillator (ICD) and usual post-MI care

6 months

Follow-up

Participants are monitored for survival and heart function after treatment

12 months

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?

Group I: ICD + Usual Care Experimental Treatment 1 Intervention

Implantable Cardioverter Defibrillator + Usual Care

Group II: Usual Care Active Control 1 Intervention

Usual post-MI care

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Cardiac Arrhythmia Network of Canada

Collaborator

Trials

14

Recruited

8,400+

Accelerating Clinical Trials Consortium

Collaborator

Trials

1

Recruited

700+

Accelerating Clinical Trials Consortium

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Alberta Innovation and Science

Collaborator

Trials

2

Recruited

740+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

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

Trials

307

Recruited

634,000+

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

1. escardio.org escardio.org/The-ESC/Press-Office/Press-releases/Implantable-cardioverter-defibrillators-did-not-improve-mortality-in-selected-heart-attack-patients-with-abnormal-heart-rhythm-markers

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5461475/

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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666501824001053

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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3913110/

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 ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa0901889

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) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11273764/

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.

7. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000000056

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 ...

8. academic.oup.com academic.oup.com/europace/article/11/4/476/416135

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%) ...

9. nature.com nature.com/articles/s41598-025-09074-z

Comparative analysis of implantable cardioverter ... A comprehensive analysis of all patients revealed that individuals with ICD implantation exhibited significantly improved survival outcomes (HR ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9743445/

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 ...