Mitral Valve Regurgitation
Conditions
Keywords
Mitral regurgitation, Mitral valve replacement
Brief summary
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.
Interventions
DEVICEEpygon™ 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.
Sponsors
Epygon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients of age ≥ 60 years. 2. Patients with primary or secondary severe symptomatic mitral valve regurgitation. 3. 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. 4. Patients with a left ventricular ejection fraction ≥ 30%. 5. Patients in NYHA functional classes III to IV. 6. Patients who have clearly accepted participation in this clinical study and who have signed the informed consent. 7. Patients who are willing to accept and undergo all protocol related requirements. 8. Patients not planning to transfer abroad.
Exclusion criteria
\- Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Safety | [Timeframe: at 30 days] | 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 | [Timeframe: at 30 days] | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient success (as per MVARC definition) | [Time frame: 12 months from implantation] | 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 | [Time frame Preoperative, 30 days, 3, 6, 12 months and yearly up to 5 years from implantation] | — |
| Six-minute walk test | [Time frame: Preoperative, 30 days, 3, 6, 12 months and yearly up to 5 years from implantation] | — |
| Quality of Life score (Kansas City Cardiomyopathy Questionnaire) | [Time frame: Preoperative, 3, 6, 12 months and yearly up to 5 years from implantation] | 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. |
| Technical Success (as per MVARC definition) | [Time Frame: immediately after procedure] | 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. |
| Device Success | [Time frame: 3, 6, 12 months and yearly up to 5 years from implantation] | 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 bioprosthesis 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) |
| Hemodynamic performance assessed by echocardiography | [Time frame: Preoperative on native mitral valve, Postoperative, 30 days, 3, 6, 12 months and yearly up to 5 years from implantation] | 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 |
| Incidence of adverse events | [Time frame: 30 days, 3, 6, 12 months and yearly up to 5 years from implantation] | — |
| Incidence of serious adverse events | [Time frame: 30 days, 3, 6, 12 months and yearly up to 5 years from implantation] | — |
| Incidence of adverse events related to device | [Time frame: 30 days, 3, 6, 12 months and yearly up to 5 years from implantation] | — |
| Incidence of adverse events related to procedure | [Time frame: 30 days, 3, 6, 12 months and yearly up to 5 years from implantation] | — |
| Absence of all-cause mortality | [Time frame: 30 days, 3, 6, 12 months and yearly up to 5 years from implantation] | — |
| Procedural Success | [Time frame: 30 days] | 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: 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 Safety | [Time frame: 3, 6, 12 months and yearly up to 5 years from implantation] | 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) |
Countries
Austria, Italy, Serbia, Spain
Contacts
Primary ContactChristophe Giot
Outcome results
None listed