RecruitingNCT05298124

MINOS

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Ottawa Heart Institute Research CorporationOne US siteView on ClinicalTrials.gov

AI Description

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.

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Who can join
adult, older adult
Participants
144
Expected completion
2028-05
Funded by
other

Conditions studied

Cardiogenic Shock, Mitral Regurgitation

What is being tested

  • DEVICE: Transcatheter edge-to-edge repair
  • OTHER: Medical therapy

What it measures

  • Primary composite outcome, The primary outcome in this clinical trial will be a composite of in-hospital all-cause mortality, cardiac transplantation, implantation of durable LVAD, or discharge on palliative inotropic therapy., Through duration of hospitalization, generally up to 12 weeks following admission

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2026-05-06

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