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Implantable Device

Implantable Defibrillator for Heart Attack (REFINE-ICD Trial)

Phase 3
Waitlist Available
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 up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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
810 Previous Clinical Trials
885,594 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,528,745 Total Patients Enrolled
Alberta Innovation and ScienceOTHER
1 Previous Clinical Trials
40 Total Patients Enrolled
MedtronicIndustry Sponsor
619 Previous Clinical Trials
763,388 Total Patients Enrolled
GE HealthcareIndustry Sponsor
301 Previous Clinical Trials
633,188 Total Patients Enrolled
Derek V Exner, MD, MPHPrincipal InvestigatorUniversity of Calgary
7 Previous Clinical Trials
7,807 Total Patients Enrolled
~0 spots leftby Dec 2024
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