Recruiting

New heart valve replacement procedure for leaky mitral valves

Plain-English translation of NCT05496998 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 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.

What is this trial?

This trial is testing the Medtronic Intrepid™ TMVR Transfemoral System, a new device designed to replace a leaky mitral valve (one of your heart's four valves) without open-heart surgery. Instead of a large surgical incision, doctors use a catheter—a thin tube—to deliver and position this new valve through blood vessels. The treatment is designed for people with severe leaking in their mitral valve who are not good candidates for traditional surgery or existing catheter-based repair options.

Current treatment options for severe mitral valve leakage are limited, especially for patients who are too sick or frail for traditional open-heart surgery or who have not had good results with existing catheter-based repair procedures. This trial exists to evaluate whether this new replacement device can safely and effectively help these patients breathe easier and feel better.

Do you qualify?

You likely qualify if…

you have moderate-to-severe or severe leaking in your mitral valve, confirmed by heart imaging, and your symptoms are affecting your quality of life
your heart doctors have agreed that you are not a good candidate for traditional mitral valve surgery or existing catheter-based repair procedures
you are committed to returning for all follow-up visits and check-ups after the procedure
you have anatomy that is suitable for this specific valve replacement device, as confirmed by your doctors
you are at least the legal age of consent in your country

You likely don't qualify if…

you have a life expectancy of less than 2 years due to other serious illnesses
you already have a surgically implanted mitral valve or a previously placed catheter-based mitral valve device
you have severe calcium buildup in your mitral valve that would prevent the new valve from being placed
you have heart function that is too weakened (ejection fraction below 25%), severe kidney failure, or liver failure
you have severe bleeding disorders, are medically unstable, or need emergency surgery

What participation looks like

If you are enrolled, you will undergo the catheter-based valve replacement procedure, which involves guided catheterization (typically through a blood vessel in your leg) to place the new valve without open-heart surgery. After the procedure, you will need to attend regular follow-up visits with your heart doctors to monitor how the new valve is working and how you are feeling. The trial will track your health and symptoms over time to see how well this treatment works for you.

AI-generated summary from trial data · Jul 7, 2026 · Not medical advice

Trial locations(37 sites)

Denmark

Aarhus University Hospital, Aarhus

Rigshospitalet, Copenhagen

Odense University Hospital, Odense

France

Clinique Pasteur, Toulouse, Cedex 03

CHU Bordeaux, Bordeaux, Pessac Cedex