Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation
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|ClinicalTrials.gov Identifier: NCT03292497|
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mitral Regurgitation||Procedure: Treatment Algorithm Procedure: No Treatment Algorithm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Echocardiographic outcome assessment will be blinded.|
|Official Title:||Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial|
|Actual Study Start Date :||January 16, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2020|
Experimental: 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
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.
Active Comparator: No treatment algorithm
Mitral valve will be repaired or replaced at surgeon's discretion.
Procedure: No Treatment Algorithm
Patients will have their valve repaired or replaced at the discretion of their surgeon.
- 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.
- 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292497
|Contact: Vincent Chan, MDemail@example.com|
|Contact: Jacqueline Fortier||613-696-7000 ext firstname.lastname@example.org|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y4W7|
|Contact: Vincent Chan 613-696-7294 email@example.com|
|Contact: Jacqueline Fortier 613-696-7000 ext 18329 firstname.lastname@example.org|
|Principal Investigator:||Vincent Chan, MD||Ottawa Heart Institute Research Corporation|