Mitral Regurgitation
Conditions
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.
Interventions
PROCEDURETreatment 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.
PROCEDURENo Treatment Algorithm
Patients will have their valve repaired or replaced at the discretion of their surgeon.
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Echocardiographic outcome assessment will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricle end-systolic volume indexed to body surface area | 12 months after surgery | Comparison of changes in the indexed volume of the left ventricle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in indexed left atrial volume | Up to 12 months after surgery | Comparison of changes in the indexed volume of the left atrium. |
| Change in right ventricle systolic pressure | Up to 12 months after surgery | Comparison of changes in the systolic pressure of the right ventricle. |
| Major adverse events | Up to 12 months after surgery | Composite endpoint of survival, recurrence of clinically-significant (\>= 2+) mitral regurgitation, and readmission to hospital for congestive heart failure |
Countries
Canada
Outcome results
None listed