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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 belowSelect...
My heart test shows reversible damage.
Select...
I have severe heart valve leakage as per the 2017 guidelines.
REVIVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 6 and12 months of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 and12 months of intervention
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 moreSecondary outcome measures
Change in indexed left atrial volume
Cumulative hospital days
Degree of left ventricular remodeling
+3 moreREVIVE 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
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Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
189 Previous Clinical Trials
92,241 Total Patients Enrolled
49 Trials studying Coronary Artery Disease
37,669 Patients Enrolled for Coronary Artery Disease
Vincent Chan, MD, MPHPrincipal InvestigatorOttawa Heart Institute Research Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart test shows reversible damage.My heart valve condition is due to a mix of causes like infection or tissue issues.I have severe heart valve leakage as per the 2017 guidelines.My heart valve's shape is not right for MitraClip treatment.I am under 18 years old.My doctors have advised against surgery for my heart condition due to high risks.I need surgery that is not for heart bypass, tricuspid valve repair, PFO closure, ASD closure, or the Maze procedure.My heart valve issue is due to a recent heart muscle injury.I have had surgery or a procedure to fix my mitral valve.
Research Study Groups:
This trial has the following groups:- Group 1: Percutaneous mitral repair
- Group 2: Mitral valve surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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