New heart valve procedure could offer a gentler option for leaky valve patients

NCT ID NCT06608823

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

Summary

This study tests a new, less invasive way to replace a leaky aortic heart valve (aortic regurgitation) using a device called the JenaValve Trilogy, compared to standard open-heart surgery. About 1,000 people with moderate to severe aortic regurgitation will be randomly assigned to get either the new procedure or surgery. Researchers will track deaths, strokes, and unplanned heart-related hospital stays over 12 months to see if the new method is as safe and effective as surgery.

What this could mean

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

Active substance

JenaValve Trilogy transcatheter heart valve system

What this could lead to

If successful, this could offer a less invasive alternative to open-heart surgery for people with a leaky aortic valve, potentially reducing recovery time and hospital stays.

What could go wrong

This is a large trial but still experimental for this specific condition. The new device may not be as durable as surgical valves, and there are risks like stroke or need for rehospitalization.

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.

aortic 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: •••••@•••••

Locations

  • Ascension St. Vincent Heart Center

    RECRUITING

    Carmel, Indiana, 46290, United States

    Contact Email: •••••@•••••

    Contact

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

  • BayCare Health

    RECRUITING

    Clearwater, Florida, 33756, United States

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

    Contact

  • Baylor Scott & White Health

    RECRUITING

    Plano, Texas, 75074, United States

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

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

    Contact

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02420, United States

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

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

    Contact

  • Buffalo General Medical Center

    RECRUITING

    Buffalo, New York, 14203, United States

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

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

    Contact

  • CPMC Sutter Health

    RECRUITING

    Burlingame, California, 94010, United States

    Contact

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

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

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

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

    Contact

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

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

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

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

    Contact

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30308, United States

    Contact

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

  • HCA North Florida

    RECRUITING

    Gainesville, Florida, 32605, United States

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

    Contact

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

  • Heart Care Centers of IL / Hinsdale Hospital

    RECRUITING

    Chicago, Illinois, 60521, United States

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

    Contact

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

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

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

    Contact

  • Houston Methodist Research Institute

    RECRUITING

    Houston, Texas, 77030, United States

    Contact

    Contact Email: •••••@•••••

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

  • Intermountain Health

    RECRUITING

    Murray, Utah, 84107, United States

    Contact

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

  • Lankenau Institute for Medical Research

    RECRUITING

    Philadelphia, Pennsylvania, 19096, United States

    Contact

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

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

  • Los Robles Medical Center

    RECRUITING

    Thousand Oaks, California, 91360, United States

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

    Contact

  • MedStar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

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

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

    Contact

  • Minneapolis Heart Institute Foundation

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

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

    Contact

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

  • Ohio Health

    RECRUITING

    Columbus, Ohio, 43214, United States

    Contact

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

  • Oregon Health & Science University (OHSU)

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact

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

  • Piedmont Healthcare

    RECRUITING

    Atlanta, Georgia, 30369, United States

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

    Contact

  • Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

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

    Contact

  • Scripps Health

    RECRUITING

    La Jolla, California, 92037, United States

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

    Contact

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

  • Sentara Norfolk

    RECRUITING

    Norfolk, Virginia, 23507, United States

    Contact

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

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

    Contact Email: •••••@•••••

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

    Contact

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

    Contact

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

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

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

    Contact

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

    Contact

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

    Contact