University of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7, Canada
NCT Number: NCT03292497
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Ottawa, Ontario, K1Y4W7, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Patients will have their valve repaired or replaced at the discretion of their surgeon.
Time frame: 12 months after surgery
Comparison of changes in the indexed volume of the left ventricle.
Time frame: Up to 12 months after surgery
Comparison of changes in the indexed volume of the left atrium.
Time frame: Up to 12 months after surgery
Comparison of changes in the systolic pressure of the right ventricle.
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
Ottawa Heart Institute Research Corporation
Other
Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial
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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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