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Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Sponsor: Ottawa Heart Institute Research Corporation
Summary
Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock. This study will be a multicenter, open-label, randomized-controlled trial with two study arms: medical therapy and TEER. Patients admitted to the Cardiac Intensive Care Unit (CICU), Cardiac Surgery Intensive Care Unit (CSICU) or Intensive Care Units (ICU) at participating centers will be recruited. The study aims to answer the question: "Does TEER in patients with SCAI stage C or D cardiogenic with concomitant moderate or greater mitral regurgitation improve outcomes as compared to medical therapy?" The study hypothesis is that TEER will lead to an overall improvement in the composite outcome as compared to the medical therapy arm.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2022-05-26
Completion Date
2025-12
Last Updated
2025-06-06
Healthy Volunteers
No
Conditions
Interventions
Transcatheter edge-to-edge repair
Transcatheter edge-to-edge repair
Medical therapy
Medical treatment in an intensive care unit
Locations (4)
Mayo Clinic
Rochester, Minnesota, United States
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada