Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

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.

Conditions

Cardiogenic Shock, Mitral Regurgitation

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Study Overview

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Study Details

Study overview

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.

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Condition
Cardiogenic Shock
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Participants or substitute decision maker is able and willing to provide written informed consent
  • 2. Age ≥ 18 years
  • 3. SCAI stage C or D cardiogenic shock with persistent inotrope/vasopressor/non-durable mechanical support or unable to wean ventilatory support due to pulmonary edema for 24 hours prior to randomization
  • 4. Greater than or equal to 3+ MR as determined by a study center's transesophageal echocardiogram (TEE)
  • 5. In the opinion of the study center's heart team the participant is anatomically eligible for TMVr with the potential to achieve \<3+ MR
  • 1. Unwilling or unable to obtain informed consent from the participant or substitute decision maker
  • 2. Revascularization of coronary artery disease performed in the 48 hours prior to randomization
  • 3. If the mechanism of MR is deemed to be degenerative, in the opinion of the heart team the participant is eligible for surgical intervention
  • 4. Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)
  • 5. Echocardiographic evidence of left sided intracardiac mass or thrombus
  • 6. Diagnosis of active infective endocarditis
  • 7. Transesophageal echocardiogram is contraindicated
  • 8. Mitral valve anatomy deemed contraindication to TMVr implantation that cannot be addressed procedurally as determined by the study center's heart team
  • 9. Any aortic valve disease greater than moderate in severity
  • 10. A known hypersensitivity or contraindication to procedure medications which cannot be adequately managed medically
  • 11. Out of hospital cardiac arrest or in-hospital cardiac arrest without documented neurologic recovery
  • 12. Plan for durable mechanical circulatory support implantation prior to TMVr
  • 13. In the opinion of the treating team, there is a significant comorbidity that would limit life expectancy in hospital
  • 14. Pregnant or planning to become pregnant in the next 6 months.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ottawa Heart Institute Research Corporation,

Study Record Dates

2025-12