Percutaneous vs Surgical Mitral Valve Repair for Mitral Valve Regurgitation
(REVIVE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Percutaneous mitral valve repair, MitraClip, Transcatheter Mitral Valve Repair (TMVr), Transcatheter Edge-to-Edge Repair (TEER), Surgical mitral valve repair/replacement, Mitral valve repair, Mitral valve replacement, Surgical mitral valve repair, Surgical mitral valve replacement for Mitral Valve Regurgitation?
Research shows that transcatheter edge-to-edge repair (TEER) is an effective treatment for mitral regurgitation, with favorable outcomes reported over three years. Studies also compare different devices like PASCAL and MitraClip, indicating that TEER is a viable option for patients with this condition.12345
How is percutaneous mitral valve repair different from other treatments for mitral valve regurgitation?
Percutaneous mitral valve repair, such as the MitraClip, is a less invasive procedure compared to traditional surgery, as it involves repairing the valve through a catheter inserted into a blood vessel rather than open-heart surgery. This approach can be particularly beneficial for patients who are at high risk for surgical complications.12367
What is the purpose of this trial?
Ischemic mitral regurgitation (MR) and coronary artery disease is common and associated with significant morbidity and mortality. Ischemic MR has been traditionally treated surgically through either valve repair or replacement at the time of concomitant bypass grafting. Although patients with ischemic MR represent a heterogeneous group, outcomes for these patients over the intermediate term is poor owing to left ventricle (LV) dysfunction causing MR and the presence of coronary disease, which portends poor survival. There is an emergence of percutaneous therapies to treat MR which have been shown to be a less invasive, safe, and viable approach to treat comorbid patients.The decision to treat ischemic MR either surgically or percutaneously is influenced by the presence of coronary disease and the ability to provide adequate revascularization. Mitral valve surgery concomitant to surgical revascularization, however, is associated with a several fold increase in mortality. In fact, the incremental risk increase is further magnified in high-risk patients. We therefore propose a novel prospective study to guide intervention for ischemic MR. Patients will be randomized to undergo surgical therapy with either mitral repair/replacement and/or concomitant coronary artery bypass grafting OR percutaneous mitral repair, followed by coronary artery bypass grafting.
Research Team
Vincent Chan, MD, MPH
Principal Investigator
Ottawa Heart Institute Research Corporation
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either surgical mitral valve repair/replacement with coronary artery bypass grafting or percutaneous mitral repair followed by coronary artery bypass grafting
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of left ventricular remodeling and presence of recurrent MR
Treatment Details
Interventions
- Percutaneous mitral valve repair
- Surgical mitral valve repair/replacement
Percutaneous mitral valve repair is already approved in United States, European Union for the following indications:
- Severe primary degenerative mitral regurgitation in patients who are high-risk candidates for surgical repair
- Moderate-to-severe or severe mitral regurgitation in certain patients with heart failure symptoms who fail to respond to guideline-directed medical therapy
- Primary mitral regurgitation
- Secondary mitral regurgitation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Heart Institute Research Corporation
Lead Sponsor