New heart valve device tested in 200 patients

NCT ID NCT04555967

Ongoing Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

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.

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.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AORTIC VALVE STENOSIS

Contacts and locations

Locations

Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark
Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany
Deutsches Herzzentrum Berlin

Berlin, 13353, Germany
Helsinki University Hospital

Helsinki, 00100, Finland
King's College Hospital London

London, SE5 9RS, United Kingdom
Medizinische Universitaet Wien

Vienna, 1090, Austria
Ospedale G. Pasquinucci

Massa, 54100, Italy
Royal Victoria Hospital Belfast

Belfast, BT12 6BA, United Kingdom
St. Paul's Hospital Vancouver

Vancouver, British Columbia, V6Z 1Y6, Canada
Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands
Universitares Herzzentrum Hamburg

Hamburg, 20251, Germany

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