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RECRUITING
NCT05298124
NA

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Sponsor: Ottawa Heart Institute Research Corporation

View on ClinicalTrials.gov

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

Interventions

DEVICE

Transcatheter edge-to-edge repair

Transcatheter edge-to-edge repair

OTHER

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