New heart valve device could spare seniors from Open-Heart surgery

NCT ID NCT06414265

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called the SATURN system, which is implanted through a tube in a blood vessel to replace a leaky mitral heart valve. It is for people aged 65 and older with severe symptoms who are not good candidates for open-heart surgery. The goal is to see if the device is safe, can be placed correctly, and reduces the leak to a mild level or less.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

SATURN Trans-Septal TMVR System (a device implanted through a catheter to replace the mitral valve)

What this could lead to

If successful, this could offer a less invasive treatment option for people with severe mitral regurgitation who are too high-risk for open-heart surgery.

What could go wrong

This is a small, early feasibility study with only 30 participants. The device may not work as expected, and there are risks like bleeding, infection, or device-related complications.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

heart failure mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Górnośląskie Centrum Medyczne

    RECRUITING

    Katowice, Poland

    Contact

  • Instituto Clinico Humanitas

    RECRUITING

    Milan, Italy

    Contact

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

    Contact

  • Royal Sussex County Hospital

    RECRUITING

    Brighton, United Kingdom

    Contact

  • Tbilisi Heart Center

    RECRUITING

    Tbilisi, Georgia

    Contact

  • Tbilisi Heart and Vascular Clinic

    RECRUITING

    Tbilisi, Georgia

  • Vilnius University Hospital Santaros Klinikos

    RECRUITING

    Vilnius, Lithuania

  • Warsaw Medical University

    RECRUITING

    Warsaw, Poland