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Clinical Trials/NCT03292497
NCT03292497
Active, Not Recruiting
N/A

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

Ottawa Heart Institute Research Corporation2 sites in 1 country110 target enrollmentJanuary 16, 2018

Overview

Phase
N/A
Intervention
Treatment Algorithm
Conditions
Mitral Regurgitation
Sponsor
Ottawa Heart Institute Research Corporation
Enrollment
110
Locations
2
Primary Endpoint
Left ventricle end-systolic volume indexed to body surface area
Status
Active, Not Recruiting
Last Updated
yesterday

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2018
End Date
November 1, 2028
Last Updated
yesterday
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Treatment Algorithm

No treatment algorithm

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

Intervention: No Treatment Algorithm

Outcomes

Primary Outcomes

Left ventricle end-systolic volume indexed to body surface area

Time Frame: 12 months after surgery

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

Secondary Outcomes

  • Change in right ventricle systolic pressure(Up to 12 months after surgery)
  • Major adverse events(Up to 12 months after surgery)
  • Change in indexed left atrial volume(Up to 12 months after surgery)

Study Sites (2)

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