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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Device Safety [Срок оценки: [Timeframe: at 30 days]]
• Device Success [Срок оценки: [Timeframe: at 30 days]]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

\- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 5 центров

• 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

Австрия · 2 центра

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

Италия · 2 центра

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

Сербия · 1 центр

• Dedinje Cardiovascular Institute — Belgrade

Идентификаторы

NCT: NCT04775108 · MINERVA FIH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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