Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

Mitral Regurgitation Clinical Trial

Official title:

Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03292497
• Other study ID #: 20170700
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 16, 2018
• Est. completion date: November 2028

Study information

• Verified date: January 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: November 2028
• Est. primary completion date: November 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Procedure:
• 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.
• No Treatment Algorithm
Patients will have their valve repaired or replaced at the discretion of their surgeon.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in indexed left atrial volume	Comparison of changes in the indexed volume of the left atrium.	Up to 12 months after surgery
Secondary	Change in right ventricle systolic pressure	Comparison of changes in the systolic pressure of the right ventricle.	Up to 12 months after surgery
Secondary	Major adverse events	Composite endpoint of survival, recurrence of clinically-significant (>= 2+) mitral regurgitation, and readmission to hospital for congestive heart failure	Up to 12 months after surgery