New catheter device aims to fix leaky heart valve without cutting chest

NCT ID NCT03745313

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

First seen Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This early study tested a device called the Edwards PASCAL system, which is threaded through a blood vessel to repair the tricuspid valve in the heart. The valve can leak, causing symptoms like shortness of breath and swelling. The study included 65 people with severe leakage who were still having symptoms despite medication. The goal was to see if the device is safe and works well enough to improve their condition.

What this could mean

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

Active substance: Edwards PASCAL Transcatheter Valve Repair System (a device implanted via a catheter to repair the tricuspid valve)
What this could lead to: If successful, this device could offer a less invasive treatment option for people with severe tricuspid regurgitation who are not candidates for open-heart surgery.
What could go wrong: This is an early feasibility study with only 65 participants, so results may not apply to everyone. Risks include serious bleeding, stroke, or need for further procedures.

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.

gastroesophageal reflux disease 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

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States
Emory University Hospital

Atlanta, Georgia, 30322, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Intermountain Medical Center

Murray, Utah, 84107, United States
Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States
Mayo Clinic

Rochester, Minnesota, 55902, United States
Morristown Medical Center

Morristown, New Jersey, 07960, United States
NYU Langone Health

New York, New York, 10016, United States
Northwestern University

Chicago, Illinois, 60611, United States
Oregon Health & Science University

Portland, Oregon, 97239, United States
St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States
The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States
University of Virginia Health System

Charlottesville, Virginia, 22908, United States

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