New heart valve procedure offers hope for High-Risk patients
NCT ID NCT04408430
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new way to replace a damaged heart valve (the mitral valve) without open-heart surgery. It uses a special valve delivered through a thin tube (catheter) for people with severe symptoms who are not healthy enough for standard surgery. The study will enroll 210 participants and compare the new procedure to standard medical treatment.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Edwards SAPIEN 3/Ultra/RESILIA valve (a replacement heart valve delivered through a catheter)
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe mitral valve disease who are too high-risk for open-heart surgery.
What could go wrong
This is an early-stage study with only 210 participants, so results may not apply to everyone. Risks include stroke, heart failure, or the valve not working as intended.
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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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Banner - University Medicine Cardiology Clinic
RECRUITINGPhoenix, Arizona, 85006, United States
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Columbia University Medical Center/NYPH
RECRUITINGNew York, New York, 10032, United States
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Dignity Health Chandler Regional Medical Center
RECRUITINGGilbert, Arizona, 85297, United States
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Contact Email: •••••@•••••
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Ignacio Chávez National Institute of Cardiology
RECRUITINGMexico City, 14080, Mexico
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Intermountain Medical Center
RECRUITINGMurray, Utah, 84107, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Mayo Clinic
ACTIVE_NOT_RECRUITINGRochester, Minnesota, 55905, United States
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Medstar Washington Hospital Center
RECRUITINGWashington D.C., District of Columbia, 200100, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Oklahoma Heart Institute Utica Office
RECRUITINGTulsa, Oklahoma, 74104, United States
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Oregon Health & Science University
RECRUITINGPortland, Oregon, 97239, United States
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Contact Email: •••••@•••••
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Pima Heart & Vascular
RECRUITINGTucson, Arizona, 85712, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Sutter Health
RECRUITINGSan Francisco, California, 94109, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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The Sentara Heart Valve and Structural Disease Center
ACTIVE_NOT_RECRUITINGNorfolk, Virginia, 23507, United States
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Uchealth Heart & Vascular Clinic Harmony Campus
ACTIVE_NOT_RECRUITINGFort Collins, Colorado, 80528, United States
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University Health
RECRUITINGSan Antonio, Texas, 78229, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Email: •••••@•••••