Post-Market Study of CORCYM Heart Valve Devices for Aortic, Mitral, and Tricuspid Valve Diseases in Real-World Use

What this Trial Is About

Researchers are conducting a global, prospective, multi-center post-market clinical follow-up study called MANTRA to monitor the safety and performance of CORCYM devices and accessories used for aortic, mitral, and tricuspid valve diseases in real-world settings. This umbrella protocol allows multiple sub-studies to be added, covering the sponsors entire cardiac surgery heart valve portfolio and including core lab assessments for some products. The study plans to enroll about 2150 subjects across up to 130 sites worldwide. The study includes three sub-studies the Aortic Sub-Study, the MitralTricuspid Sub-Study excluding Memo 4D, and the Memo 4D Sub-Study. Subjects diagnosed with valve diseases and considered suitable for treatment with specific CORCYM devices can participate in the corresponding sub-study. Follow-up visits are planned at discharge, 30 days post-implantation, and annually for up to 10 years. The Memo 4D sub-study involves additional echocardiogram imaging assessed by a core lab. Participants will provide informed consent and share baseline, procedural, hospitalization, discharge, and follow-up data during standard medical care. They will complete quality of life questionnaires at baseline, 30 days, and one year. Researchers will monitor device success at 30 days as the primary outcome and track mortality, adverse cardiovascular events, rehospitalizations, valve function, and patient outcomes up to 10 years. Safety and performance data will be collected continuously throughout the study.

CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting