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Clinical Trial

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

NCT: NCT05298124 · RECRUITING

NCT IDNCT05298124
StatusRECRUITING
Start Date2022-05-26
Completion2028-05

Brief 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.

Frequently Asked Questions

What is Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock?

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock is a clinical trial registered under NCT05298124. Current status: RECRUITING.

What is the status of NCT05298124?

The current status of NCT05298124 (Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock) is: RECRUITING.

When did Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock start?

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock started on 2022-05-26.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.