InnovHeart
CASSINI-US is a prospective, single-arm, multicenter early feasibility study enrolling up to 15 patients at up to 5 sites in the United States (US). The purpose of the study is to evaluate the technical (implant) feasibility, and safety, and performance of the SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. Primary objectives evaluate the implant feasibility, and acute safety and performance of the SATURN TS TMVR System. The secondary objective and additional outcome measures characterize the long-term safety and performance of the SATURN TS TMVR System.
The SATURN Bioprosthesis is designed to be implanted in the native mitral heart valve without open-heart surgery, extracorporeal circulation, cardiac arrest or removal of the failed native valve. The SATURN Bioprosthesis consists of the annular structure (Annular Segments) and the valve (SATURN Valve). The valve supports a set of prosthetic leaflets that are the functional elements of the bioprosthesis. The valve is made of a self-expandable Nitinol frame supports three bovine pericardium leaflets. The valve is assembled with the annular structure through two connecting blocks mounted on the…
Inclusion Criteria: * Age 18 years or older. * Symptomatic, moderate to severe or severe, functional or mixed, mitral regurgitation (≥ Grade 3+). * NYHA functional Class ≥ II. If Class IV, patient must be ambulatory. * Ability to tolerate oral anticoagulation. * Ability to qualify for bailout surgery (which may include open heart surgery). * High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team. * Willing and able to complete study-related assessments and questionnaires. Exclusion Criteria: * Purely degenerative (organic/primary…
Implant of SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation