New heart valve device aims to fix leaky tricuspid without open surgery

NCT ID NCT05913908

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study is testing a new device called the DUO System, which is placed through a catheter to reduce leakage in the tricuspid valve. The study will include 15 people with severe tricuspid regurgitation who still have symptoms despite medical therapy. The main goal is to see if the device is safe and works properly.

What this could mean

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

Active substance

DUO Transcatheter Tricuspid Coaptation Valve System (a device implanted via catheter to reduce tricuspid valve leakage)

What this could lead to

If successful, this could offer a less invasive treatment option for people with severe tricuspid regurgitation who are not candidates for open-heart surgery.

What could go wrong

This is a very early feasibility study with only 15 participants, so results may not apply to everyone. The device could cause serious complications like bleeding, stroke, or heart damage.

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 valve disorder tricuspid valve disorder tricuspid 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

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

  • Contact

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

Locations

  • Allina Health Minneapolis Heart Institute Foundation

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

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

    Contact

  • Ascension Via Christi Research

    RECRUITING

    Wichita, Kansas, 67214, United States

    Contact

    Contact Email: •••••@•••••

  • Columbia University Medical Center/NYPH

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

    Contact

  • Dignity Health St. Joseph's Hospital & Medical Center

    RECRUITING

    Phoenix, Arizona, 85013, United States

    Contact

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

  • Intermountain Health

    RECRUITING

    Salt Lake City, Utah, 84111, United States

    Contact

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

  • Los Robles Hospital & Medical Center

    RECRUITING

    Thousand Oaks, California, 91360, United States

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

    Contact

  • Medical University of Silesia

    RECRUITING

    Katowice, 40-635, Poland

    Contact

  • Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym

    RECRUITING

    Warsaw, Warsaw, 04-628, Poland

    Contact

    Contact Phone: •••-•••-••••

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

    Contact

  • OhioHealth Research Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

    Contact

    Contact

    Contact

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

    Contact Email: •••••@•••••

    Contact

    Contact

  • San Antonio Methodist

    ENROLLING_BY_INVITATION

    San Antonio, Texas, 78229, United States

  • UPMC Pinnacle Harrisburg

    RECRUITING

    Harrisburg, Pennsylvania, 17050, United States

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

    Contact

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

    Contact

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

  • Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu

    RECRUITING

    Poznan, Poznan, 60-355, Poland

    Contact

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