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.
Single group
Epygon™ Transcatheter Mitral Valve System
DeviceThe 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.
Device Safety
defined as the absence of major device or procedure related serious adverse events evaluated on the following clinical events: 1. death 2. major cardiac structural complications (as per MVARC definitions) 3. life-threatening bleeding (MVARC scale) 4. any prosthesis-related dysfunction, migration, thrombosis, or other complication, that require surgery or repeated intervention. 5. myocardial infarction or coronary ischemia requiring PCI or CABG 6. severe hypotension, heart failure or respiratory failure requiring intravenous vasopressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for ≥ 48H 7. major vascular complications 8. stroke 9. stage 2 or 3 acute kidney injury (includes new dialysis)
Device Success
1. Technical Success (as per MVARC definition) defined as alive patient at exit from procedure room, with all of the following: 1. Successful access, delivery and retrieval of the Epygon delivery system 2. Successful deployment and positioning of the Epygon Transcatheter mitral valve 3. Freedom from additional emergency surgery or re-intervention related to the device or access procedure. 2. Continued intended safety and performance of the device, including: 1. No evidence of structural or functional failure (as per MVARC definition) 2. No specific device-related technical failure issues and complications (as per MVARC definition) 3. Reduction of mitral regurgitation (MR) to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) without significant mitral stenosis (post-procedure EOA ≥ 1.5 cm2 with a transmitral gradient \< 5mmHg) and with no greater than mild (1+) paravalvular MR (and without associated hemolysis)
Device Safety
defined as absence of major device or procedure related serious adverse events evaluated on the following clinical events: 1. death 2. major cardiac structural complications 3. life-threatening bleeding (MVARC scale) 4. any prosthesis-related dysfunction, migration, thrombosis, or other complication, that require surgery or repeated intervention. 5. myocardial infarction or coronary ischemia requiring PCI or CABG 6. severe hypotension, heart failure or respiratory failure requiring intravenous vasopressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for ≥ 48H 7. major access complications 8. stroke 9. stage 2 or 3 acute kidney injury (includes new dialysis)
Patient success (as per MVARC definition)
All of the following must be present: 1. Device success (either optimal or acceptable) 2. Patient returned to the pre-procedural setting 3. No rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, heart failure) 4. Improvement from baseline in symptoms (e.g., NYHA improvement by ≥ 1 functional class) 5. Improvement from baseline in functional status (e.g., 6-min walk test improvement by ≥ 50 m) 6. Improvement from baseline in quality-of-life (e.g., Kansas City Cardiomyopathy Questionnaire improvement by ≥ 10)
Evaluation of clinical status on the basis of the NYHA functional classification
Six-minute walk test
