First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
NCT ID: NCT04775108
Last Updated: 2023-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2021-02-01
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implanted patients
Implantation of Epygon mitral valve prosthesis
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Patients with clinical/anatomical conditions unsuitable for a transapical surgical approach.
3. Patients who have previously undergone implantation of a transcatheter aortic valve prosthesis.
4. Patients with previous implantation of a mitral heart valve prosthesis.
5. Patients with previous implantation of a mitral annuloplasty ring.
6. Patients needing emergency or life-saving interventions.
7. Patients with a heavily calcified mitral annulus and/or anterior mitral leaflet.
8. Patients with active infection or endocarditis (suspect endocarditis included).
9. Patients with echocardiographic evidence of intracardiac mass or thrombus.
10. 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).
11. Patients with an active peptic ulcer or upper GI bleeding within the prior 30 days.
12. Patients with a documented allergy towards contrast media, and to any compound of the investigated medical device.
13. Patients that have neurological disease severely affecting ambulation or day to day functioning.
14. Patients with any stroke within the prior 30 days.
15. Patients with senile dementia, according to the advice from a specialized neurologist.
16. Patients in whom transesophageal echocardiography (TEE) is contraindicated since TEE is used for both preoperative screening and guidance during implant procedure.
17. 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.
18. Patients unable to understand and sign the Informed Consent Form in absence of legal representative.
19. Patients with a lack of capacity to consent.
20. Patients unable to read and write.
21. Patients with left ventricular apex aneurysm;
22. Patients with aorto-mitral angle \<120°;
23. Patients with a systolic/diastolic mitral valve area assessed as not compatible with the sizing policy matrix defined by the Sponsor.
24. Patients with ventricular morphology (position of papillary muscles, ventricular wall hypertrophy) unsuitable with the study valve design;
25. Patients with aorto-mitral angle \<120°;
26. Patients with a systolic/diastolic mitral valve area assessed as not compatible with the sizing policy matrix defined by the Sponsor.
60 Years
ALL
No
Sponsors
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Epygon
INDUSTRY
Responsible Party
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Locations
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Medical University of Innsbruck
Innsbruck, , Austria
Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
Vienna, , Austria
Careggi Hospital Florence Italy Largo Brambilla
Florence, , Italy
A.O.U. Citta della Salute e della Scienza di Torino
Torino, , Italy
Dedinje Cardiovascular Institute
Belgrade, , Serbia
Hospital German Trias i Pujol
Badalona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Nikolaos Bonaros
Role: primary
Martin Andreas
Role: primary
Pierluigi Stefano
Role: primary
Mauro Rinaldi
Role: primary
Slobodan Micovic
Role: primary
Christian Munoz Guijosa
Role: primary
Antonino Ginel Iglesias
Role: primary
Luis Carlos Maroto Castellanos
Role: primary
Sergio Canovas Lopez
Role: primary
José Miguel Borrego Dominguez
Role: primary
Other Identifiers
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MINERVA FIH
Identifier Type: -
Identifier Source: org_study_id
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