Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

NCT03292497 | Active Not Recruiting DMC

• 1 other identifier: 20170700
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Left ventricle end-systolic volume indexed to body surface area

  Comparison of changes in the indexed volume of the left ventricle.

  12 months after surgery

Secondary Outcomes (3)

• Change in indexed left atrial volume

  Up to 12 months after surgery

• Change in right ventricle systolic pressure

  Up to 12 months after surgery

• Major adverse events

  Up to 12 months after surgery

Study Arms (2)

Treatment algorithm

EXPERIMENTAL

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

Procedure: Treatment Algorithm

No treatment algorithm

ACTIVE COMPARATOR

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

Procedure: No Treatment Algorithm

Interventions

Treatment Algorithm 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.

Treatment algorithm

No Treatment Algorithm PROCEDURE

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

No treatment algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe ischemic mitral valve regurgitation
• years of age, and able to provide informed consent.

You may not qualify if:

• Mixed mitral valve pathology
• Acute ischemic mitral regurgitation

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Vincent Chan, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Echocardiographic outcome assessment will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: January 16, 2018
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)