Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation
Primary Purpose
Mitral Regurgitation
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Treatment Algorithm
No Treatment Algorithm
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Regurgitation
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
Sites / Locations
- University of Ottawa Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment algorithm
No treatment algorithm
Arm Description
Mitral valve will be replaced if posterior leaflet tethering angle >=25 degrees. Mitral valve will be repaired if posterior leaflet tethering angle <25 degrees
Mitral valve will be repaired or replaced at surgeon's discretion.
Outcomes
Primary Outcome Measures
Left ventricle end-systolic volume indexed to body surface area
Comparison of changes in the indexed volume of the left ventricle.
Secondary Outcome Measures
Change in indexed left atrial volume
Comparison of changes in the indexed volume of the left atrium.
Change in right ventricle systolic pressure
Comparison of changes in the systolic pressure of the right ventricle.
Major adverse events
Composite endpoint of survival, recurrence of clinically-significant (>= 2+) mitral regurgitation, and readmission to hospital for congestive heart failure
Full Information
NCT ID
NCT03292497
First Posted
September 20, 2017
Last Updated
February 6, 2023
Sponsor
Ottawa Heart Institute Research Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03292497
Brief Title
Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation
Official Title
Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Echocardiographic outcome assessment will be blinded.
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment algorithm
Arm Type
Experimental
Arm Description
Mitral valve will be replaced if posterior leaflet tethering angle >=25 degrees.
Mitral valve will be repaired if posterior leaflet tethering angle <25 degrees
Arm Title
No treatment algorithm
Arm Type
Active Comparator
Arm Description
Mitral valve will be repaired or replaced at surgeon's discretion.
Intervention Type
Procedure
Intervention Name(s)
Treatment Algorithm
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
No Treatment Algorithm
Intervention Description
Patients will have their valve repaired or replaced at the discretion of their surgeon.
Primary Outcome Measure Information:
Title
Left ventricle end-systolic volume indexed to body surface area
Description
Comparison of changes in the indexed volume of the left ventricle.
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Change in indexed left atrial volume
Description
Comparison of changes in the indexed volume of the left atrium.
Time Frame
Up to 12 months after surgery
Title
Change in right ventricle systolic pressure
Description
Comparison of changes in the systolic pressure of the right ventricle.
Time Frame
Up to 12 months after surgery
Title
Major adverse events
Description
Composite endpoint of survival, recurrence of clinically-significant (>= 2+) mitral regurgitation, and readmission to hospital for congestive heart failure
Time Frame
Up to 12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Chan, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation
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