Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

Study Overview
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Brief Summary
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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
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Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Procedure: Treatment Algorithm
* Procedure: No Treatment Algorithm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment algorithm<br>Mitral valve will be replaced if posterior leaflet tethering angle >=25 degrees. Mitral valve will be repaired if posterior leaflet tethering angle <25 degrees | Procedure: Treatment Algorithm<br>* 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.<br>|
| Active Comparator: No treatment algorithm<br>Mitral valve will be repaired or replaced at surgeon's discretion. | Procedure: No Treatment Algorithm<br>* Patients will have their valve repaired or replaced at the discretion of their surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricle end-systolic volume indexed to body surface area | Comparison of changes in the indexed volume of the left ventricle. | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in indexed left atrial volume | Comparison of changes in the indexed volume of the left atrium. | Up to 12 months after surgery | 
| Change in right ventricle systolic pressure | Comparison of changes in the systolic pressure of the right ventricle. | 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 | Up to 12 months after surgery |