Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Ottawa Heart Institute Research Corporation
Study ID
NCT05298124
Status
Recruiting
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Conditions

  • Cardiogenic Shock
  • Mitral Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcatheter edge-to-edge repair — DEVICE
    Transcatheter edge-to-edge repair
  • Medical therapy — OTHER
    Medical treatment in an intensive care unit

Study Details

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 Dates

Start date
May 26, 2022
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transcatheter edge-to-edge repair
    The experimental arm includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support plus transcatheter edge-to-edge repair
  • Active Comparator: Medical therapy
    Medical therapy includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support.

Primary Outcome Measure

Primary composite outcome [ Time Frame: Through duration of hospitalization, generally up to 12 weeks following admission ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Benjamin Hibbert, MD PhD
[email protected]

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By research site
Mayo Clinic· Rochester, MN

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