Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

Not Applicable

Active, not recruiting

• Conditions: Mitral Regurgitation
• Interventions: Procedure: Treatment Algorithm; Procedure: No Treatment Algorithm

• Registration Number: NCT03292497
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Study Start: 2018-01-16
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10
• Primary Completion: 2028-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment algorithm	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
No treatment algorithm	No Treatment Algorithm	Mitral valve will be repaired or replaced at surgeon's discretion.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Change in indexed left atrial volume	Up to 12 months after surgery	Comparison of changes in the indexed volume of the left atrium.

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada