Clinical Trials

Inclusion Criteria:

• 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 Criteria:

• 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 (this exclusion criterion does not apply to participants with a ruptured papillary muscle).
• 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/1/23. Questions regarding updates should be directed to the study team contact.