Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2028-11-30

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.

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Detailed Description

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Conditions

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Mitral Regurgitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Echocardiographic outcome assessment will be blinded.

Study Groups

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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

Group Type EXPERIMENTAL

Treatment Algorithm

Intervention Type PROCEDURE

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.

No treatment algorithm

Mitral valve will be repaired or replaced at surgeon's discretion.

Group Type ACTIVE_COMPARATOR

No Treatment Algorithm

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE