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

 1. Subjects of age ≥ 60 years;

 2. Subjects with primary or secondary severe symptomatic mitral valve regurgitation;

 3. Subjects 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;

 4. Subjects with a left ventricular ejection fraction ≥ 30%;

 5. Subjects in NYHA functional classes III to IV;

 6. Subjects who have clearly accepted participation in a clinical evaluation and who have
 signed the informed consent;

 7. Subjects who are willing to undergo all the medical check-ups and instrumental
 examinations and laboratory tests that are part of this present protocol;

 8. Patients not planning to transfer abroad.

 Exclusion Criteria:

 -  Clinical exclusion criteria (preoperative screening)

 1. Subjects involved in other clinical assessments for drugs or devices that could
 interfere or alter the study endpoints;

 2. Subjects with clinical/anatomical conditions unsuitable for a transapical
 surgical approach;

 3. Subjects who have previously undergone implantation of a transcatheter aortic
 valve prosthesis;

 4. Subjects with previous implantation of a mitral heart valve prosthesis;

 5. Subjects with previous implantation of a mitral annuloplasty ring;

 6. Subjects needing emergency or life-saving interventions;

 7. Subjects with a heavily calcified mitral annulus and/or anterior mitral leaflet;

 8. Subjects with active infection or endocarditis (suspect endocarditis included);

 9. Subjects with echocardiographic evidence of intracardiac mass or thrombus;

 10. Subject which suffered an acute myocardial infarction within 30 days of the
 intended treatment (defined as: Q wave MI, or non-Q wave MI with elevation of
 CK-MB ≥ 3 times normal in the absence of pathological Q waves), if no assay for
 CK-MB was performed, elevation of CK level to >2 times normal without new Q
 waves, or elevated Troponin level is also considered a non-Q wave MI);

 11. Subjects with an active peptic ulcer or upper GI bleeding within the prior 30
 days;

 12. Subjects with a documented allergy towards contrast media;

 13. Subjects that have neurological disease severely affecting ambulation or day to
 day functioning;

 14. Subjects with any stroke within the prior 30 days;

 15. Subjects with senile dementia, according to the advice from a specialized
 neurologist;

 16. Subjects in whom transesophageal echocardiography (TEE) is contraindicated since
 TEE is used for both preoperative screening and guidance during implant
 procedure.

 -  Echographic exclusion criteria (preoperative screening) 17. Subjects with left
 ventricular apex aneurysm; 18. Subjects with aorto-mitral angle <120°; 19. Subjects
 with a systolic/diastolic mitral valve area assessed compatible with the sizing policy
 matrix defined by the Sponsor.

 -  Computerized Tomographic (CT) exclusion criteria (preoperative screening) 20. Subjects
 with ventricular morphology (position of papillary muscles, ventricular wall
 hypertrophy) unsuitable with the study valve design; 21. Subjects with aorto-mitral
 angle <120°; 22. Subjects with a systolic/diastolic mitral valve area assessed
 compatible with the sizing policy matrix defined by the Sponsor.