Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Recruiting now · Not applicable

Conditions studied: Cardiogenic Shock, Mitral Regurgitation

In brief

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 facts

Study ID: NCT05298124
Run by: Ottawa Heart Institute Research Corporation
People needed: 144
Starts: 2022-05-26
Expected to finish: 2028-05-01
Last updated by the study team: 2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Mayo Clinic — Rochester, Minnesota, United States (enrolling)
University of Ottawa Heart Institute — Ottawa, Ontario, Canada (enrolling)
Sunnybrook Hospital — Toronto, Ontario, Canada
St. Michael's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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