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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.
Must not have
Patients with mixed mitral valve pathology, including fibroelastic deficiency, rheumatic valve disease, ruptured mitral valve chordae, mitral valve endocarditis.
Age < 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 and12 months of intervention
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart valve condition is due to a mix of causes like infection or tissue issues.
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I am under 18 years old.
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My doctors have advised against surgery for my heart condition due to high risks.
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My heart valve issue is due to a recent heart muscle injury.
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I have had surgery or a procedure to fix my mitral valve.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hospitalization rate for congestive heart failure
Mortality rate
Rate of Stroke
+1 more
Secondary study objectives
Degree of left ventricular remodeling
Number of Participants with worsening in heart failure symptoms
Presence of recurrent MR ≥2+

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
196 Previous Clinical Trials
93,617 Total Patients Enrolled
50 Trials studying Coronary Artery Disease
37,781 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
~12 spots leftby Aug 2025
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