Implantable Defibrillator for Heart Attack

(REFINE-ICD Trial)

Recruiting at 77 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

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

I am taking medication for irregular heartbeats.

Clinical indication for an ICD or cardiac resynchronization ICD

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+

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