New catheter device aims to fix leaky heart valve without cutting chest
NCT ID NCT03745313
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
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.
Disclaimer
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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.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032, United States
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Emory University Hospital
Atlanta, Georgia, 30322, United States
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Henry Ford Hospital
Detroit, Michigan, 48202, United States
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Intermountain Medical Center
Murray, Utah, 84107, United States
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Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
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Mayo Clinic
Rochester, Minnesota, 55902, United States
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Morristown Medical Center
Morristown, New Jersey, 07960, United States
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NYU Langone Health
New York, New York, 10016, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
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The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
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University of Virginia Health System
Charlottesville, Virginia, 22908, United States