Treatment options for ischemic mitral regurgitation and coronary artery disease
A Prospective Randomized Trial Comparing the Surgical Treatment of Ischemic Mitral Regurgitation Versus Percutaneous Mitral Repair Followed by Surgical Revascularization
This study is testing whether less invasive treatments or traditional surgery work better for people with severe mitral regurgitation and coronary artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT04822675 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of percutaneous and surgical interventions for patients suffering from ischemic mitral regurgitation (MR) and coronary artery disease. It aims to determine the best approach to treat severe MR in patients with reversible myocardial ischemia, comparing traditional surgical methods with less invasive percutaneous therapies. The study focuses on improving patient outcomes by addressing the complexities of treating these comorbid conditions. Participants will be carefully selected based on specific inclusion and exclusion criteria to ensure safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with severe ischemic mitral regurgitation and reversible myocardial ischemia.
Not a fit: Patients with mixed mitral valve pathology or those at prohibitive surgical risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to improved treatment options and outcomes for patients with ischemic mitral regurgitation and coronary artery disease.
How similar studies have performed: Other studies have shown promise with percutaneous therapies for mitral regurgitation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Vincent Chan, MD, MPH — Ottawa Heart Institute Research Corporation
- Study coordinator: Mary Zhang, MD, PhD
- Email: mzhang@ottawaheart.ca
- Phone: 613-696-7230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.