New catheter device aims to repair leaky mitral valves in high-risk patients

NCT ID NCT04820764

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a new device called the CardioMech Mitral Valve Repair System in 25 people with moderate to severe mitral regurgitation (a leaky heart valve) who are at intermediate or high risk for surgery. The device is delivered through a catheter to repair the valve without open-heart surgery. The main goals are to check safety and see if the device reduces the leak.

What this could mean

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

Active substance

CardioMech Mitral Valve Repair System (a device implanted via catheter to repair the mitral valve)

What this could lead to

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

What could go wrong

This is a very early feasibility study with only 25 people, so results may not apply to everyone. The device could cause serious side effects or fail to improve valve function.

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.

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

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

  • Contact

    Email: •••••@•••••

Locations

  • Ascension St. Francis via Christi

    RECRUITING

    Wichita, Kansas, 67226, United States

    Contact

    Contact

    Contact Email: •••••@•••••

  • Ascension St. Thomas West

    RECRUITING

    Nashville, Tennessee, 37205, United States

    Contact

    Contact Email: •••••@•••••

    Contact

  • Atrium Health Sanger Heart and Vascular Institute

    ACTIVE_NOT_RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Baylor Scott & White, The Heart Hospital

    RECRUITING

    Plano, Texas, 75093, United States

    Contact Email: •••••@•••••

    Contact

  • Cardiovascular Institute of Los Robles Health System

    ACTIVE_NOT_RECRUITING

    Thousand Oaks, California, 91360, United States

  • CentraCare Heart & Vascular Center

    RECRUITING

    Saint Cloud, Minnesota, 56303, United States

    Contact Email: •••••@•••••

    Contact

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

    Contact

    Contact Email: •••••@•••••

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

    Contact

    Contact Email: •••••@•••••

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55902, United States

    Contact Email: •••••@•••••

    Contact

  • NYU Langone

    RECRUITING

    New York, New York, 10016, United States

    Contact

    Contact Email: •••••@•••••

  • Northwestern University

    RECRUITING

    Evanston, Illinois, 60208, United States

    Contact

    Contact Email: •••••@•••••

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

    Contact Email: •••••@•••••

    Contact