Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

University of Ottawa Heart Institute

Status: Active, not recruiting

Conditions: Mitral Regurgitation

Treatments: Procedure: Treatment Algorithm; Procedure: No Treatment Algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT03292497

20170700

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Treatment algorithm

Experimental group

Description:

Mitral valve will be replaced if posterior leaflet tethering angle \>=25 degrees. Mitral valve will be repaired if posterior leaflet tethering angle \<25 degrees

Treatment:

Procedure: Treatment Algorithm

No treatment algorithm

Active Comparator group

Description:

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

Treatment:

Procedure: No Treatment Algorithm