REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial

University of Ottawa Heart Institute

Status: Enrolling

Conditions: Coronary Artery Disease; Mitral Valve Insufficiency

Treatments: Procedure: Percutaneous mitral valve repair; Procedure: Surgical mitral valve repair/replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT04822675

20210317

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Presence of reversible myocardial ischemia confirmed by preoperative myocardial viability study using radionuclide imaging.

Exclusion criteria

1. Patients with mixed mitral valve pathology, including fibroelastic deficiency, rheumatic valve disease, ruptured mitral valve chordae, mitral valve endocarditis.
2. Patients with acute ischemic MR, defined as MR caused by papillary muscle infarction and rupture.
3. Age < 18 years.
4. Prohibitive surgical risk or contraindications to Cardiopulmonary bypass (CPB) as defined by the Heart Team.
5. Need for a concomitant surgical procedure, excluding Coronary artery bypass grafting (CABG), tricuspid valve repair, Patent foramen ovale (PFO) closure, Atrial septal defect (ASD) closure and Maze procedure.
6. Prior mitral valve repair procedure (percutaneous or surgical).
7. Leaflet anatomy unsuitable for MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Percutaneous mitral repair

Experimental group

Description:

Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair.

Treatment:

Procedure: Percutaneous mitral valve repair

Mitral valve surgery

Active Comparator group

Description:

Surgical mitral valve surgery +/- coronary artery bypass grafting

Treatment:

Procedure: Surgical mitral valve repair/replacement