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Procedure

Percutaneous vs Surgical Mitral Valve Repair for Mitral Valve Regurgitation (REVIVE Trial)

N/A
Recruiting
Led By Vincent Chan, MD, MPH
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of reversible myocardial ischemia confirmed by preoperative myocardial viability study using radionuclide imaging.
Patients with severe ischemic Mitral regurgitation (MR), as defined by the 2017 American Society of Echocardiography (ASE) guidelines for noninvasive evaluation of native valvular regurgitation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 and12 months of intervention
Awards & highlights

REVIVE Trial Summary

This trial will help determine if percutaneous mitral valve repair is a viable treatment option for ischemic MR.

Who is the study for?
The REVIVE trial is for adults with severe ischemic mitral regurgitation and reversible myocardial ischemia. It's not for those under 18, with certain heart valve conditions, previous mitral repairs, or who can't undergo cardiopulmonary bypass.Check my eligibility
What is being tested?
This study compares two treatments for ischemic MR in the context of coronary artery disease: surgical repair/replacement of the mitral valve possibly combined with bypass grafting versus a less invasive percutaneous repair followed by bypass grafting.See study design
What are the potential side effects?
Potential side effects include risks associated with heart surgery such as bleeding, infection, and reactions to anesthesia. Percutaneous repair may involve complications like blood vessel damage or issues related to MitraClip device placement.

REVIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart test shows reversible damage.
Select...
I have severe heart valve leakage as per the 2017 guidelines.

REVIVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 and12 months of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 and12 months of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hospitalization rate for congestive heart failure
Mortality rate
Rate of Stroke
+1 more
Secondary outcome measures
Change in indexed left atrial volume
Cumulative hospital days
Degree of left ventricular remodeling
+3 more

REVIVE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Percutaneous mitral repairExperimental Treatment1 Intervention
Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair.
Group II: Mitral valve surgeryActive Control1 Intervention
Surgical mitral valve surgery +/- coronary artery bypass grafting

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,494 Total Patients Enrolled
49 Trials studying Coronary Artery Disease
37,816 Patients Enrolled for Coronary Artery Disease
Vincent Chan, MD, MPHPrincipal InvestigatorOttawa Heart Institute Research Corporation

Media Library

Percutaneous mitral valve repair (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04822675 — N/A
Coronary Artery Disease Research Study Groups: Percutaneous mitral repair, Mitral valve surgery
Coronary Artery Disease Clinical Trial 2023: Percutaneous mitral valve repair Highlights & Side Effects. Trial Name: NCT04822675 — N/A
Percutaneous mitral valve repair (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04822675 — N/A

Frequently Asked Questions

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

How many participants are currently engaged in this research project?

"Affirmative. The information available on clinicaltrials.gov specifies that this medical trial began recruiting patients as of August 12, 2021 and the latest update was posted on November 14, 2022. To complete the study, 80 individuals need to be enrolled at a solitary site."

Answered by AI

Are there any unfilled vacancies in this clinical trial?

"Affirmative. According to the details published on clinicaltrials.gov, this medical study is actively enlisting participants with a view of beginning trials in 2021 and concluding them towards the end of 2022. Remarkably, only 80 patients need to be recruited from one facility for these tests to commence."

Answered by AI
~27 spots leftby Aug 2025