New heart valve and simpler procedure could change aortic stenosis treatment
NCT ID NCT05036018
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two newer self-expanding heart valves and a minimalist approach (using only local anesthesia, avoiding extra tubes) against standard care for people with severe aortic valve stenosis. About 836 participants will be randomly assigned to receive either the new valve or standard valve, and either the minimalist or standard procedure. The goal is to see if the newer options reduce complications like death, stroke, bleeding, and infections.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
ACURATE neo2 heart valve and a minimalist procedure (local anesthesia only, no extra tubes or catheters)
What this could lead to
If successful, this could show that newer valves and a simpler approach are safer and just as effective as standard care for aortic valve replacement.
What could go wrong
This is a mid-stage study, so results are not final. The simpler approach may not be suitable for all patients, and there are still risks like stroke or bleeding.
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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Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Leipzig, 04289, Germany
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Helios Klinikum Wuppertal
Wuppertal, 42283, Germany
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Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545, Germany
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Herzzentrum München
München, 80636, Germany
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LMU Klinikum München
München, 81377, Germany
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St.-Johannes-Hospital Dortmund
Dortmund, 44137, Germany
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Universitätsklinikum Gießen
Giessen, 35392, Germany
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Universitätsklinikum Köln
Cologne, 50937, Germany
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Universitätsklinikum Tübingen
Tübingen, 72076, Germany
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Zentralklinik Bad Berka
Bad Berka, 99437, Germany