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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
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.
Patients will have their valve repaired or replaced at the discretion of their surgeon.
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Left ventricle end-systolic volume indexed to body surface area
Comparison of changes in the indexed volume of the left ventricle.
Time frame: 12 months after surgery
Change in indexed left atrial volume
Comparison of changes in the indexed volume of the left atrium.
Time frame: Up to 12 months after surgery
Change in right ventricle systolic pressure
Comparison of changes in the systolic pressure of the right ventricle.
Time frame: Up to 12 months after surgery
Major adverse events
Composite endpoint of survival, recurrence of clinically-significant (\>= 2+) mitral regurgitation, and readmission to hospital for congestive heart failure
Time frame: Up to 12 months after surgery
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