New treatment for severe mitral valve insufficiency using a transcatheter valve system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and feasibility of the Epygon™ Transcatheter Mitral Valve System, designed for minimally invasive replacement of the native mitral valve. The valve is a bio prosthesis made from bovine pericardium mounted on a NiTinol stent. It targets adult patients aged 60 and older who suffer from severe symptomatic mitral regurgitation and are not candidates for conventional surgery. The trial involves a thorough assessment by a multidisciplinary Heart Team to ensure appropriate patient selection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients of age ≥ 60 years.
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:

\- Clinical exclusion criteria (preoperative screening)

1. Patients involved in other clinical assessments for drugs or devices that could interfere or alter the study endpoints.
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.

    \- Echographic exclusion criteria (preoperative screening)
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.

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

Where it's running

• 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
• Hospital German Trias i Pujol
  Badalona, Spain Recruiting
• Hospital de la Santa Creu i Sant Pau
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Christophe Giot
• Email: christophe.giot@affluentmedical.com
• Phone: +33 4 42 95 12 20

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.