Early feasibility study, single-arm registry design
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 years of age or older.
✓. Greater than moderate degenerative or functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
✓. Patient must present with an STS Score less than 10%
✓. High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications) as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
✓. Mitral valve anatomy deemed unsuitable to be treated with an approved edge-to-edge repair system (e.g., retracted posterior leaflet, lack of leaflet tissue, calcified or cleft posterior leaflet) as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
✓. Patient is approved by an independent Patient Eligibility Committee
✓. New York Heart Association (NYHA) Functional Class III or IV
✓. Patient willing to participate in study and provide signed EC-approved informed consent.