New heart valve device tested in 200 patients
NCT ID NCT04555967
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a newer version of a heart valve device, called the SAPIEN 3 Ultra, in 200 people with severe aortic stenosis (a narrowed heart valve). The valve is implanted through a tube in an artery, avoiding open-heart surgery. Researchers are checking how well the valve works and tracking safety issues like stroke or bleeding.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
SAPIEN 3 Ultra heart valve device
What this could lead to
If successful, this could confirm that the SAPIEN 3 Ultra valve is safe and effective for treating severe aortic stenosis without open-heart surgery.
What could go wrong
This is a post-market study, so the device is already approved; risks include stroke, bleeding, or need for a pacemaker. Results may not apply to all patients.
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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Aarhus University Hospital, Skejby
Aarhus, 8200, Denmark
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Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
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Deutsches Herzzentrum Berlin
Berlin, 13353, Germany
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Helsinki University Hospital
Helsinki, 00100, Finland
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King's College Hospital London
London, SE5 9RS, United Kingdom
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Medizinische Universitaet Wien
Vienna, 1090, Austria
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Ospedale G. Pasquinucci
Massa, 54100, Italy
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Royal Victoria Hospital Belfast
Belfast, BT12 6BA, United Kingdom
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St. Paul's Hospital Vancouver
Vancouver, British Columbia, V6Z 1Y6, Canada
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Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
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Universitares Herzzentrum Hamburg
Hamburg, 20251, Germany