HighLife SAS
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
Protocol Title: An Early Feasibility Study of the HighLife 28mm Transcatheter Trans-Septal Mitral Valve Replacement System Protocol # HL-2019-01, ver. 5.0 Phase: United States Early Feasibility Study Investigational Devices: The HighLife 28mm Trans-Septal Mitral Valve and its delivery systems. These devices compose the HighLife Trans-septal Mitral Valve Replacement (TSMVR) System. * Size 28 mm TMV (CLARITY valve) * Size 28 mm TMV-L (CLARITY large annulus valve/ LAV) Intended Use: The HighLife TSMVR system is intended for the trans-septal access percutaneous mitral valve replacement in p…
Inclusion Criteria: * Age ≥ 18 years * Severe mitral regurgitation * New York Heart Association (NYHA) Functional Class II, III or ambulatory IV. * Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months * Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions * Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions * Patient meets the anatomical criteria fo…
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system