New Heart Valve Implant for Severe Mitral Valve Leakage

Plain-English translation of NCT04775108 on ClinicalTrials.gov ↗ · Source last updated August 2023 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

This is one of the first times this treatment has been tested in people.

What is this trial?

This is a first-in-human study testing the Epygon Transcatheter Mitral Valve, a new artificial heart valve made from cow tissue attached to a special metal frame. The valve is designed to replace a severely leaking mitral valve (the valve that controls blood flow in your heart) through a minimally invasive procedure—meaning smaller incisions than traditional open-heart surgery. This treatment is being tested in patients with severe mitral valve leakage who are not candidates for conventional surgery.

Many patients with severe mitral valve leakage cannot safely undergo traditional heart surgery due to age, other medical conditions, or anatomical factors. This new treatment could offer these patients a less invasive option to repair their heart function and improve their quality of life.

Do you qualify?

You likely qualify if…

you are at least 60 years old
you have been diagnosed with severe mitral valve leakage that causes symptoms like shortness of breath or fatigue
you have been evaluated by a heart team and deemed unsuitable for traditional surgery and valve repair procedures
your heart's pumping function is still reasonably preserved (ejection fraction of at least 30%)
you are willing to commit to all study visits and follow-up requirements and not planning to move abroad

You likely don't qualify if…

you have had a recent heart attack (within the past 30 days)
you have a known allergy to contrast dye or any materials in the valve
you have had a recent stroke or significant neurological problems affecting your daily life
you have had a previous heart valve implant or repair in your mitral valve
you have a serious infection or active heart infection (endocarditis)

What participation looks like

You would undergo a minimally invasive procedure in which doctors insert the new valve through a small incision between your ribs, guided by imaging. The procedure uses a specialized catheter (thin tube) to deliver and position the valve. You would need imaging tests before the procedure (including an echocardiogram, which uses ultrasound to look at your heart) and regular follow-up visits afterward to monitor how well the valve is working and your overall heart function.

AI-generated summary from trial data · Jun 22, 2026 · Not medical advice

Trial locations(10 sites)

Austria

Medical University of Innsbruck, Innsbruck

Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery, Vienna

Italy

Careggi Hospital Florence Italy Largo Brambilla, Florence

A.O.U. Citta della Salute e della Scienza di Torino, Torino

Serbia

Dedinje Cardiovascular Institute, Belgrade