Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
• Heart Team determines subject is not a suitable candidate for conventional surgical treatment due to degree of MAC present and the subject will likely benefit from transcatheter valve implantation
• Symptomatic, severe mitral regurgitation, as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR
• NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
• Age 18 years or older at time of consent
• Not a member of a vulnerable population per the investigator's judgment
• The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions, including complying with study required testing and follow-up visits, and has provided written informed consent