Status:
RECRUITING
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
Lead Sponsor:
Epygon
Conditions:
Mitral Valve Regurgitation
Eligibility:
All Genders
60+ years
Phase:
NA
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 EPYG...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04775108
Start Date
February 1 2021
End Date
December 31 2029
Last Update
August 7 2023
Active Locations (10)
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1
Medical University of Innsbruck
Innsbruck, Austria
2
Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
Vienna, Austria
3
Careggi Hospital Florence Italy Largo Brambilla
Florence, Italy
4
A.O.U. Citta della Salute e della Scienza di Torino
Torino, Italy