Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Ottawa Heart Institute Research Corporation
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.
Description
Current management strategies for patients with SCAI stage C through E cardiogenic shock include management in a cardiac intensive care unit (CICU) or cardiac surgery intensive care unit (CSICU) with intravenous inotropes (i.e. medications to increase the pumping function of the heart), vasopressors (i.e. medications to increase blood pressure), ventilatory support, and/or mechanical circulatory support. Importantly, with the exception of revascularization, little data exists demonstrating the ability to alter prognosis in patients with cardiogenic shock. Mitral regurgitation may be seen in t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 Exclusion C…
Interventions
- DeviceTranscatheter edge-to-edge repair
Transcatheter edge-to-edge repair
- OtherMedical therapy
Medical treatment in an intensive care unit
Locations (4)
- Mayo ClinicRochester, Minnesota
- University of Ottawa Heart InstituteOttawa, Ontario
- Sunnybrook HospitalToronto, Ontario
- St. Michael's HospitalToronto, Ontario