Status:
RECRUITING
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Cardiogenic Shock
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Participants or substitute decision maker is able and willing to provide written informed consent
- Age ≥ 18 years
- 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
- Greater than or equal to 3+ MR as determined by a study center's transesophageal echocardiogram (TEE)
- 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
- Unwilling or unable to obtain informed consent from the participant or substitute decision maker
- Revascularization of coronary artery disease performed in the 48 hours prior to randomization
- If the mechanism of MR is deemed to be degenerative, in the opinion of the heart team the participant is eligible for surgical intervention
- Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)
- Echocardiographic evidence of left sided intracardiac mass or thrombus
- Diagnosis of active infective endocarditis
- Transesophageal echocardiogram is contraindicated
- Mitral valve anatomy deemed contraindication to TMVr implantation that cannot be addressed procedurally as determined by the study center's heart team
- Any aortic valve disease greater than moderate in severity
- A known hypersensitivity or contraindication to procedure medications which cannot be adequately managed medically
- Out of hospital cardiac arrest or in-hospital cardiac arrest without documented neurologic recovery
- Plan for durable mechanical circulatory support implantation prior to TMVr
- In the opinion of the treating team, there is a significant comorbidity that would limit life expectancy in hospital
- Pregnant or planning to become pregnant in the next 6 months.
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT05298124
Start Date
May 26 2022
End Date
December 1 2025
Last Update
June 6 2025
Active Locations (4)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
3
Sunnybrook Hospital
Toronto, Ontario, Canada, M4N 3M5
4
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1T8