REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial

Last updated: January 8, 2024
Sponsor: Ottawa Heart Institute Research Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Heart Disease

Cardiac Disease

Treatment

Percutaneous mitral valve repair

Surgical mitral valve repair/replacement

Clinical Study ID

NCT04822675
20210317
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with severe ischemic Mitral regurgitation (MR), as defined by the 2017American Society of Echocardiography (ASE) guidelines for noninvasive evaluation ofnative valvular regurgitation.
  2. Presence of reversible myocardial ischemia confirmed by preoperative myocardialviability study using radionuclide imaging.

Exclusion

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 infarctionand rupture.
  3. Age < 18 years.
  4. Prohibitive surgical risk or contraindications to Cardiopulmonary bypass (CPB) asdefined 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 septaldefect (ASD) closure and Maze procedure.
  6. Prior mitral valve repair procedure (percutaneous or surgical).
  7. Leaflet anatomy unsuitable for MitraClip implantation, proper MitraClip positioning onthe leaflets or sufficient reduction in MR by the MitraClip.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Percutaneous mitral valve repair
Phase:
Study Start date:
August 12, 2021
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Active - Recruiting

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