New Catheter-Based valve replacement could offer hope for leaky heart valve patients
NCT ID NCT04221490
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new device called the Edwards EVOQUE system, which replaces the tricuspid valve using a thin tube (catheter) instead of open-heart surgery. The trial includes 228 people with moderate or severe tricuspid regurgitation who still have symptoms despite medical therapy. The goal is to see if the device is safe and can reduce the leak, improve symptoms, and avoid major complications.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Edwards EVOQUE tricuspid valve replacement system (a device implanted through a catheter to replace the tricuspid valve)
- What this could lead to
- If successful, this 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-stage study with only 228 participants, so results may not apply to everyone. Risks include major adverse events like stroke, bleeding, or need for re-intervention.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor Heart Hopsital Plano
Plano, Texas, 75093, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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CHU Bordeaux, Hôpital Cardiologique Haut Lévêque
Pessac, 33600, France
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Clinique Pasteur
Toulouse, 31076, France
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Columbia University Irving Medical Center / NYPH
New York, New York, 10032, United States
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Emory University
Atlanta, Georgia, 30308, United States
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Henry Ford Hospital
Detroit, Michigan, 48202, United States
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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InselSpital University Hospital Bern
Bern, 3010, Switzerland
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Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)
Québec, G1V 4G5, Canada
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Massachusetts General Hospital Boston
Boston, Massachusetts, 02114, United States
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Montefiore Medical Center
The Bronx, New York, 10467, United States
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Northwestern University
Evanston, Illinois, 60208, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
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St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
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St. Paul's Hospital Vancouver
Vancouver, British Columbia, V6Z1Y6, Canada
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Stanford University
Stanford, California, 94305, United States
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University of Virginia Health System
Charlottesville, Virginia, 22908, United States
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