New Catheter-Based valve repair could help heart patients avoid surgery

NCT ID NCT03382457

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

Summary

This study is testing a device called the Edwards Cardioband FIT, which is used to repair the tricuspid valve in people with tricuspid regurgitation (a leaky heart valve). The device is delivered through a catheter, avoiding open-heart surgery. The trial includes 75 participants with moderate or worse tricuspid regurgitation who still have symptoms despite medical therapy. The goal is to see if the device is safe and effective at reducing the leak and improving symptoms.

What this could mean

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

Active substance

Edwards Cardioband FIT Valve Repair System (a device implanted via catheter to repair the tricuspid valve)

What this could lead to

If it works, this could offer a less invasive treatment option for people with tricuspid regurgitation, reducing symptoms and the need for open-heart surgery.

What could go wrong

This is an early-stage study with only 75 participants, so results may not apply to everyone. The procedure carries risks like bleeding, infection, or device 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.

tricuspid valve insufficiency

As listed by the trial registrant

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

Contacts and locations

Locations

  • Columbia University Medical Center /New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07962, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    Portland, Oregon, 97293, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States