Status:
RECRUITING
REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Mitral Valve Insufficiency
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 v...
Eligibility Criteria
Inclusion
- 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.
- Presence of reversible myocardial ischemia confirmed by preoperative myocardial viability study using radionuclide imaging.
Exclusion
- Patients with mixed mitral valve pathology, including fibroelastic deficiency, rheumatic valve disease, ruptured mitral valve chordae, mitral valve endocarditis.
- Patients with acute ischemic MR, defined as MR caused by papillary muscle infarction and rupture.
- Age \< 18 years.
- Prohibitive surgical risk or contraindications to Cardiopulmonary bypass (CPB) as defined by the Heart Team.
- 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.
- Prior mitral valve repair procedure (percutaneous or surgical).
- Leaflet anatomy unsuitable for MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip.
Key Trial Info
Start Date :
August 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04822675
Start Date
August 12 2021
End Date
August 1 2026
Last Update
January 10 2024
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7