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

Official title

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

Overview

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

• Device 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.

Primary outcome measures

• Device Safety [Time frame: [Timeframe: at 30 days]]
• Device Success [Time frame: [Timeframe: at 30 days]]

Secondary outcome measures (12)

• Device Safety [Time frame: [Time frame: 3, 6, 12 months and yearly up to 5 years from implantation]]
• Patient success (as per MVARC definition) [Time frame: [Time frame: 12 months from implantation]]
• Evaluation of clinical status on the basis of the NYHA functional classification [Time frame: [Time frame Preoperative, 30 days, 3, 6, 12 months and yearly up to 5 years from implantation]]
• Six-minute walk test [Time frame: [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: [Time frame: Preoperative, 3, 6, 12 months and yearly up to 5 years from implantation]]
• Hemodynamic performance assessed by echocardiography [Time frame: [Time frame: Preoperative on native mitral valve, Postoperative, 30 days, 3, 6, 12 months and yearly up to 5 years from implantation]]
• Technical Success (as per MVARC definition) [Time frame: [Time Frame: immediately after procedure]]
• Device Success [Time frame: [Time frame: 3, 6, 12 months and yearly up to 5 years from implantation]]
• Procedural Success [Time frame: [Time frame: 30 days]]
• Incidence of adverse events [Time frame: [Time frame: 30 days, 3, 6, 12 months and yearly up to 5 years from implantation]]
• Incidence of serious adverse events [Time frame: [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: [Time frame: 30 days, 3, 6, 12 months and yearly up to 5 years from implantation]]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

\- Clinical exclusion criteria (preoperative screening)

• 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.
• Patients in whom transesophageal echocardiography (TEE) is contraindicated since TEE is used for both preoperative screening and guidance during implant procedure.
• Patients who is unwilling or deemed by the Investigator to be unwilling to comply with the requirements of the protocol, or subject with a history of non-compliance.
• Patients unable to understand and sign the Informed Consent Form in absence of legal representative.
• Patients with a lack of capacity to consent.
• Patients unable to read and write.

\- Echographic exclusion criteria (preoperative screening)

• Patients with left ventricular apex aneurysm;
• Patients with aorto-mitral angle <120°;
• Patients with a systolic/diastolic mitral valve area assessed as not compatible with the sizing policy matrix defined by the Sponsor.

\- Computerized Tomographic (CT) exclusion criteria (preoperative screening)

• Patients with ventricular morphology (position of papillary muscles, ventricular wall hypertrophy) unsuitable with the study valve design;
• Patients with aorto-mitral angle <120°;
• Patients with a systolic/diastolic mitral valve area assessed as not compatible with the sizing policy matrix defined by the Sponsor.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 5 centers

• Hospital German Trias i Pujol — Badalona
• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Clinico San Carlos — Madrid
• Hospital Virgen de la Arrixaca — Murcia
• Hospital Universitario Virgen Del Rocio — Seville

Austria · 2 centers

• Medical University of Innsbruck — Innsbruck
• Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery — Vienna

Italy · 2 centers

• Careggi Hospital Florence Italy Largo Brambilla — Florence
• A.O.U. Citta della Salute e della Scienza di Torino — Torino

Serbia · 1 center

• Dedinje Cardiovascular Institute — Belgrade

Identifiers

NCT: NCT04775108 · MINERVA FIH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗