The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device.
The EPYGON VALVE is a bio prosthesis, composed by a functional assembly of bovine pericardium on a NiTinol stent.
The purpose of this trial is to assess the safety and feasibility of the Epygon™ Transcatheter mitral valve and the transapical delivery system, in adult patients with severe, symptomatic mitral regurgitation.
Patients of age ≥ 60 years.
Patients with primary or secondary severe symptomatic mitral valve regurgitation.
Patients with severe, symptomatic mitral regurgitation and who have been evaluated by a multidisciplinary Heart Team and deemed to be ineligible for conventional valve surgery and not eligible for transcatheter repair.
Patients with a left ventricular ejection fraction ≥ 30%.
Patients involved in other clinical assessments for drugs or devices that could interfere or alter the study endpoints.
Patients with clinical/anatomical conditions unsuitable for a transapical surgical approach.
Patients who have previously undergone implantation of a transcatheter aortic valve prosthesis.
Patients with previous implantation of a mitral heart valve prosthesis.