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New device aims to fix leaky heart valve without open surgery

NCT ID NCT04905017

Recruiting now Disease control Sponsor: Trisol Medical Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a new device called the Trisol System, which replaces the tricuspid valve using a tube inserted through blood vessels, avoiding open-heart surgery. It includes 30 adults with moderate or severe tricuspid regurgitation who have symptoms like shortness of breath or fatigue. The main goals are 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
Transcatheter tricuspid valve replacement device (Trisol System)
What this could lead to
If successful, this could provide a less invasive treatment option for people with tricuspid regurgitation who cannot have open-heart surgery.
What could go wrong
This is a very early feasibility study with only 30 people, so safety and effectiveness are not yet proven. The device may cause serious complications like bleeding, stroke, or need for emergency surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

tricuspid valve insufficiency

As listed by the trial registrant

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

TRICUSPID REGURGITATION

Contacts and locations

Study contacts

  • Contact

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

Locations

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

    Contact

  • Columbia University Medical Center/NYPH

    RECRUITING

    New York, New York, 10032, United States

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

  • Main Line Health / Lankenau Institute for Medical Research

    NOT_YET_RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

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

    Contact

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

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

    Contact

    Contact

  • University of Virginia Cardiology

    RECRUITING

    Charlottesville, Virginia, 22908, United States

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

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

    Contact

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

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