Percutaneous vs Surgical Mitral Valve Repair for Mitral Valve Regurgitation
(REVIVE Trial)
Recruiting in Palo Alto (17 mi)
Overseen byVincent Chan, MD, MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ottawa Heart Institute Research Corporation
Disqualifiers: Mixed mitral pathology, Acute ischemic MR, Age < 18, others
No Placebo Group
Trial Summary
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.
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.
12345How 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.
12367Eligibility 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
My heart test shows reversible damage.
I have severe heart valve leakage as per the 2017 guidelines.
Exclusion Criteria
My heart valve condition is due to a mix of causes like infection or tissue issues.
My heart valve's shape is not right for MitraClip treatment.
I am under 18 years old.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo either surgical mitral valve repair/replacement with coronary artery bypass grafting or percutaneous mitral repair followed by coronary artery bypass grafting
2 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of left ventricular remodeling and presence of recurrent MR
12 months
Multiple visits (in-person and virtual)
Participant Groups
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.
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
Percutaneous mitral valve repair is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as MitraClip for:
- 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
🇪🇺 Approved in European Union as MitraClip for:
- Primary mitral regurgitation
- Secondary mitral regurgitation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Ottawa Heart InstituteOttawa, Canada
Loading ...
Who Is Running the Clinical Trial?
Ottawa Heart Institute Research CorporationLead Sponsor
References
Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. [2023]Mitral valve transcatheter edge-to-edge repair (M-TEER) is an effective option for treatment of mitral regurgitation (MR). We previously reported favorable 2-year outcomes for the PASCAL transcatheter valve repair system.
Transcatheter mitral valve replacement or repair for secondary mitral regurgitation: a propensity score-matched analysis. [2023]This study aimed to compare outcomes after transcatheter mitral valve replacement (TMVR) and mitral valve transcatheter edge-to-edge repair (M-TEER) for the treatment of secondary mitral regurgitation (SMR).
Characteristics and outcomes of patients undergoing transcatheter mitral valve replacement with the Tendyne system. [2023]Transcatheter mitral valve replacement (TMVR) has emerged as alternative to transcatheter edge-to-edge repair (TEER) for treatment of mitral regurgitation (MR); however, the role of TMVR with the Tendyne system among established treatments of MR is not well defined. We assessed characteristics and outcomes of patients treated with the Tendyne system in the current clinical practice.
Outcomes After Transcatheter Edge-to-Edge Mitral Valve Repair According to Mitral Regurgitation Etiology and Cardiac Remodeling. [2022]Transcatheter edge-to-edge repair (TEER) has been increasingly used for selected patients with mitral regurgitation (MR), but limited data are available regarding clinical outcomes in patients with varied etiology and mechanism of MR.
Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis. [2023]Transcatheter edge-to-edge repair (TEER) of the mitral valve (MV) can be performed using the PASCAL or MitraClip devices. Few studies offer a head-to-head outcome comparison of these two devices.
[Mitral valve: When conservative, when surgical, when interventional therapy?] [2022]The management of severe symptomatic mitral regurgitation is in contrast to the aortic-valve-intervention more challenging due to the complex mitral-valve anatomy. In primary mitral regurgitation surgical therapy is recommended, whereas there are various therapeutic options in secondary mitral regurgitation. Besides the established mitral-valve Transcatheter Edge-to-Edge-Repair (M-TEER) and the interventional annuloplasty - devices dynamic developments have recently been made in the field of Transcatheter Mitral Valve Replacement-therapy (TMVR). This article surveys the current recommendations and available therapeutic options in mitral regurgitation.
Operator Experience and Outcomes of Transcatheter Mitral Valve Repair in the United States. [2020]Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset.