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NCT Number: NCT03292497

Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

No Treatment Algorithm

Procedure

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

Primary outcomes

  1. 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

  1. Change in indexed left atrial volume

    Time frame: Up to 12 months after surgery

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

  2. Change in right ventricle systolic pressure

    Time frame: Up to 12 months after surgery

    Comparison of changes in the systolic pressure of the right ventricle.

  3. Major adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Sep 25, 2017
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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