First Human Study of Sutra Hemi-Valve to Evaluate Safety and Efficacy in Patients With Mitral Regurgitation
Study to evaluate the feasibility, safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for surgical treatment.
• Subject is greater than 18 years of age at time of enrollment.
• Subject has moderate-severe or severe symptomatic mitral regurgitation who are considered high surgical risk for conventional mitral repair or replacement, as assessed by institutional multidisciplinary heart team.
• New York Heart Association (NYHA) Functional Class II and above.
• Subject anatomy is suitable for transfemoral and transeptal device delivery and meets sizing criteria for Sutra Hemi-valve TMVR System.
• Subject willing and able to provide informed consent and able to comply with the study protocol and follow up.
• Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure