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ACTIVE NOT RECRUITING
NCT03292497
NA

Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

Sponsor: Ottawa Heart Institute Research Corporation

View on ClinicalTrials.gov

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.

Official title: Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2018-01-16

Completion Date

2028-11

Last Updated

2024-01-10

Healthy Volunteers

No

Interventions

PROCEDURE

Treatment Algorithm

Patients will have their procedure dictated by a treatment algorithm. They will have their mitral valve replaced if the posterior leaflet tethering angle \>=25 degrees, or repaired if the posterior leaflet tethering angle \<25 degrees.

PROCEDURE

No Treatment Algorithm

Patients will have their valve repaired or replaced at the discretion of their surgeon.

Locations (1)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada