Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial
Overview
- Phase
- N/A
- Intervention
- Treatment Algorithm
- Conditions
- Mitral Regurgitation
- Sponsor
- Ottawa Heart Institute Research Corporation
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Left ventricle end-systolic volume indexed to body surface area
- Status
- Active, Not Recruiting
- Last Updated
- yesterday
Overview
Brief Summary
Ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking, as a result of changes in the muscle of the heart caused by coronary artery disease Ischemic mitral regurgitation, or IMR, is normally treated by repairing or replacing the mitral valve. Currently, we don't have very strong evidence showing which patients might benefit from mitral valve repair and which might benefit from replacement, and surgeons tend to repair or replace valves based on their preference or experience. Some surgeons, including Dr. Vincent Chan, the Principal Investigator, believe that the decision to repair or replace the valve should be based on specific measurements of the mitral valve. This study will randomly assign patients to receive either the current standard of care for ischemic mitral regurgitation, which is valve repair or replacement based on the surgeon's preference, or to have their treatment decided by a set of criteria called an algorithm. This algorithm will assign patients with certain mitral valve measurements to repair, and others to replacement. Patients will be followed for 12 months after surgery, to compare whether patients whose treatment was decided by the algorithm did better than patients whose treatment was decided by surgeon preference.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Severe ischemic mitral valve regurgitation
- •18 years of age, and able to provide informed consent.
Exclusion Criteria
- •Mixed mitral valve pathology
- •Acute ischemic mitral regurgitation
Arms & Interventions
Treatment algorithm
Mitral valve will be replaced if posterior leaflet tethering angle \>=25 degrees. Mitral valve will be repaired if posterior leaflet tethering angle \<25 degrees
Intervention: Treatment Algorithm
No treatment algorithm
Mitral valve will be repaired or replaced at surgeon's discretion.
Intervention: No Treatment Algorithm
Outcomes
Primary Outcomes
Left ventricle end-systolic volume indexed to body surface area
Time Frame: 12 months after surgery
Comparison of changes in the indexed volume of the left ventricle.
Secondary Outcomes
- Change in right ventricle systolic pressure(Up to 12 months after surgery)
- Major adverse events(Up to 12 months after surgery)
- Change in indexed left atrial volume(Up to 12 months after surgery)