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

NCT04775108 | Recruiting DMC

• 1 other identifier: MINERVA FIH
• Study Type: interventional
• Target: 40
• Locations: 4 countries
• Sites: 10

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.

Conditions

Mitral Valve Regurgitation

Keywords

Mitral regurgitation; Mitral valve replacement

Outcome Measures

Primary Outcomes (2)

• 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)

  [Timeframe: at 30 days]

• 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)

  [Timeframe: at 30 days]

Secondary Outcomes (14)

• Device Safety

  [Time frame: 3, 6, 12 months and yearly up to 5 years from implantation]

• Patient success (as per MVARC definition)

  [Time frame: 12 months from implantation]

• 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]

Study Arms (1)

Implanted patients

EXPERIMENTAL

Implantation of Epygon mitral valve prosthesis

Device: Epygon™ Transcatheter Mitral Valve System

Interventions

Epygon™ Transcatheter Mitral Valve System DEVICE

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.

Implanted patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with previous implantation of a mitral annuloplasty ring.
• Patients needing emergency or life-saving interventions.
• Patients with a heavily calcified mitral annulus and/or anterior mitral leaflet.
• Patients with active infection or endocarditis (suspect endocarditis included).
• Patients with echocardiographic evidence of intracardiac mass or thrombus.
• Patients 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).
• Patients with an active peptic ulcer or upper GI bleeding within the prior 30 days.
• Patients with a documented allergy towards contrast media, and to any compound of the investigated medical device.
• Patients that have neurological disease severely affecting ambulation or day to day functioning.
• Patients with any stroke within the prior 30 days.
• Patients with senile dementia, according to the advice from a specialized neurologist.

Sponsors & Collaborators

• Epygon: lead

Study Sites (10)

Medical University of Innsbruck

Innsbruck, Austria

RECRUITING

Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery

Vienna, Austria

RECRUITING

Careggi Hospital Florence Italy Largo Brambilla

Florence, Italy

RECRUITING

A.O.U. Citta della Salute e della Scienza di Torino

Torino, Italy

RECRUITING

Dedinje Cardiovascular Institute

Belgrade, Serbia

NOT YET RECRUITING

Hospital German Trias i Pujol

Badalona, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, Spain

RECRUITING

Hospital Virgen de la Arrixaca

Murcia, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Christophe Giot

CONTACT

+33 4 42 95 12 20; christophe.giot@affluentmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: February 1, 2021
• Primary Completion: October 31, 2024
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

AU (2); SE (1); IT (2); ES (5)