First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System (MINERVA FIH)
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 in NYHA functional classes III to IV.
• Patients who have clearly accepted participation in this clinical study and who have signed the informed consent.
• Patients who are willing to accept and undergo all protocol related requirements.
• Patients not planning to transfer abroad.