Treatment Algorithm for Mitral Valve Regurgitation

Recruiting in Palo Alto (17 mi)

Overseen byVincent Chan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ottawa Heart Institute Research Corporation

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults who can consent and have severe ischemic mitral valve regurgitation, a heart condition where the valve leaks due to coronary artery disease. It's not for those with mixed valve issues or acute cases of this condition.

Inclusion Criteria

I have severe leakage in my heart's mitral valve due to poor blood supply.

I am 18 or older and can give my consent.

Exclusion Criteria

I have a mixed condition affecting my mitral valve.

I have a heart valve issue due to a recent blockage.

Participant Groups

The study compares two approaches: one group gets standard care (valve repair/replacement based on surgeon choice), while the other follows a treatment algorithm deciding between repair or replacement based on specific measurements of the mitral valve.

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment algorithmExperimental Treatment1 Intervention

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 II: No treatment algorithmActive Control1 Intervention

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

Treatment Algorithm is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Ketalar for: