Clinical Study of Epygon Transcatheter Mitral Valve System for Adults 60 and Older With Severe Mitral Valve Regurgitation

What this Trial Is About

Researchers are evaluating the safety and feasibility of the Epygon Transcatheter mitral valve system in adults aged 60 and older who have severe and symptomatic mitral valve regurgitation. This innovative bio prosthetic valve is made from bovine pericardium mounted on a NiTinol stent and is designed for minimally invasive replacement of the native mitral valve. The study aims to provide an alternative for patients who are not eligible for conventional valve surgery or transcatheter repair. The trial involves implanting the Epygon mitral valve prosthesis using a transapical delivery system. This minimally invasive procedure replaces the damaged mitral valve through a dedicated device. Participants will receive this implant and be monitored to assess the devices safety and success shortly after implantation and over time. Participants will undergo various assessments including echocardiography to evaluate heart function, six-minute walk tests, and quality of life questionnaires before and after implantation. Follow-up visits occur at 30 days, 3, 6, 12 months, and yearly up to 5 years to monitor device safety, clinical status, hemodynamic performance, and adverse events. The study tracks multiple outcomes such as procedural success, device safety, and patient functional improvement throughout this period.

First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System