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

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)

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)

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

1. Prosthetic mean atrio-ventricular ΔP < 5 mm Hg
2. Prosthetic Effective Orifice Area (EOA) ≥ 1.5 cm2
3. Mitral valve regurgitation reduction (vs. preoperative) of at least 1 grade and not more than moderate (2+)
4. Prosthetic paravalvular valve leakage (PVL) not more than mild (1+) without hemolysis

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.

1. Technical Success (as per MVARC definition) defined as alive patient at exit from procedure room, with all of the following:
2. Successful access, delivery and retrieval of the Epygon delivery system
3. Successful deployment and positioning of the Epygon bioprosthesis
4. Freedom from additional emergency surgery or re-intervention related to the device or access procedure.
5. Continued intended safety and performance of the device, including:
6. No evidence of structural or functional failure (as per MVARC definition)
7. No specific device-related technical failure issues and complications (as per MVARC definition)
8. 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)

All of the following must be present:

1. Device success (either optimal or acceptable), And
2. Absence of major device or procedure related serious adverse events, including:
3. death
4. major cardiac structural complications (as per MVARC definitions)
5. life-threatening bleeding (MVARC scale)
6. any prosthesis-related dysfunction, migration, thrombosis, or other complication, that require surgery or repeated intervention.
7. myocardial infarction or coronary ischemia requiring PCI or CABG
8. 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
9. major vascular complications
10. stroke
11. stage 2 or 3 acute kidney injury (includes new dialysis).