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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with severe ischemic Mitral regurgitation (MR), as defined by the 2017American Society of Echocardiography (ASE) guidelines for noninvasive evaluation ofnative valvular regurgitation.
- Presence of reversible myocardial ischemia confirmed by preoperative myocardialviability study using radionuclide imaging.
Exclusion
Exclusion Criteria:
- 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 infarctionand rupture.
- Age < 18 years.
- Prohibitive surgical risk or contraindications to Cardiopulmonary bypass (CPB) asdefined 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 septaldefect (ASD) closure and Maze procedure.
- Prior mitral valve repair procedure (percutaneous or surgical).
- 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
CanadaActive - Recruiting
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