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Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

NCT05298124 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Cardiogenic Shock
  • Mitral Regurgitation

Interventions

DEVICE

Transcatheter edge-to-edge repair

Transcatheter edge-to-edge repair

OTHER

Medical therapy

Medical treatment in an intensive care unit

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-26
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05298124 on ClinicalTrials.gov