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Implantable Device

Implantable Cardioverter Defibrillator + Usual Care for Heart Attack (REFINE-ICD Trial)

Phase 3

Recruiting

Led By Derek V Exner, MD, MPH

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average follow-up 5 years.

Awards & highlights

REFINE-ICD Trial Summary

This trial will test whether an implantable defibrillator can help people who have had a heart attack in the last five years, have abnormal test results from a 24-hour heart monitor, and have low normal heart function.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort or infection at the implant site, inappropriate shocks from the device, or complications related to device maintenance.

REFINE-ICD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average follow-up 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~average follow-up 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and average follow-up 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mortality

Secondary outcome measures

Appropriate ICD therapies

Arrhythmic death

Arrhythmic syncope

+3 more

REFINE-ICD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Implantable Cardioverter Defibrillator + Usual CareExperimental Treatment1 Intervention

Medtronic ICD

Group II: Usual CareActive Control1 Intervention

Usual post-MI care

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cardiac Arrhythmia Network of CanadaOTHER

11 Previous Clinical Trials

6,969 Total Patients Enrolled

Accelerating Clinical Trials ConsortiumUNKNOWN

University of CalgaryLead Sponsor

792 Previous Clinical Trials

868,454 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than 25 years being sought out for participation in this medical study?

"To be considered for enrollment in this study, participants must be at least 18 years old and no more than 80 years of age."

Answered by AI

At how many different sites is this medical study being administered?

"This clinical trial is currently ongoing at various esteemed institutions like McGill University Health Centre in Montreal, Vanderbilt University Medical Center in Nashville, and the University of Western Ontario in London. Additionally, there are 40 more sites participating in this study."

Answered by AI

Has the combination of Implantable Cardioverter Defibrillator and standard care received approval from FDA?

"Based on the phase of this trial, where there is existing evidence backing its effectiveness and numerous rounds of safety data collection, our evaluation at Power rates the safety of Implantable Cardioverter Defibrillator + Usual Care as 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction

Dr. Derek Exner 2011. "Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00673842.

All > Heart Attack > Washington