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

NCT ID NCT03382457

Ongoing Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

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.

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

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

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