New heart valve procedure could offer a gentler option for leaky valve patients
NCT ID NCT06608823
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new, less invasive way to replace a leaky aortic heart valve (aortic regurgitation) using a device called the JenaValve Trilogy, compared to standard open-heart surgery. About 1,000 people with moderate to severe aortic regurgitation will be randomly assigned to get either the new procedure or surgery. Researchers will track deaths, strokes, and unplanned heart-related hospital stays over 12 months to see if the new method is as safe and effective as surgery.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
JenaValve Trilogy transcatheter heart valve system
What this could lead to
If successful, this could offer a less invasive alternative to open-heart surgery for people with a leaky aortic valve, potentially reducing recovery time and hospital stays.
What could go wrong
This is a large trial but still experimental for this specific condition. The new device may not be as durable as surgical valves, and there are risks like stroke or need for rehospitalization.
Disclaimer
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the original study
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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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Study contacts
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Contact
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Ascension St. Vincent Heart Center
RECRUITINGCarmel, Indiana, 46290, United States
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BayCare Health
RECRUITINGClearwater, Florida, 33756, United States
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Baylor Scott & White Health
RECRUITINGPlano, Texas, 75074, United States
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02420, United States
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Buffalo General Medical Center
RECRUITINGBuffalo, New York, 14203, United States
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CPMC Sutter Health
RECRUITINGBurlingame, California, 94010, United States
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Columbia University Medical Center
RECRUITINGNew York, New York, 10032, United States
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Emory University Hospital
RECRUITINGAtlanta, Georgia, 30308, United States
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HCA North Florida
RECRUITINGGainesville, Florida, 32605, United States
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Heart Care Centers of IL / Hinsdale Hospital
RECRUITINGChicago, Illinois, 60521, United States
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Henry Ford Health
RECRUITINGDetroit, Michigan, 48202, United States
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Houston Methodist Research Institute
RECRUITINGHouston, Texas, 77030, United States
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Intermountain Health
RECRUITINGMurray, Utah, 84107, United States
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Lankenau Institute for Medical Research
RECRUITINGPhiladelphia, Pennsylvania, 19096, United States
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Los Robles Medical Center
RECRUITINGThousand Oaks, California, 91360, United States
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MedStar Washington Hospital Center
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Minneapolis Heart Institute Foundation
RECRUITINGMinneapolis, Minnesota, 55407, United States
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Ohio Health
RECRUITINGColumbus, Ohio, 43214, United States
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Oregon Health & Science University (OHSU)
RECRUITINGPortland, Oregon, 97239, United States
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Piedmont Healthcare
RECRUITINGAtlanta, Georgia, 30369, United States
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Robert Wood Johnson University Hospital
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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Scripps Health
RECRUITINGLa Jolla, California, 92037, United States
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Sentara Norfolk
RECRUITINGNorfolk, Virginia, 23507, United States
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The Christ Hospital
RECRUITINGCincinnati, Ohio, 45219, United States
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The Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Washington
RECRUITINGSeattle, Washington, 98195, United States
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