New heart valve and simpler procedure could change aortic stenosis treatment

NCT ID NCT05036018

Ongoing Disease control Sponsor: Leipzig Heart Science gGmbH Source: ClinicalTrials.gov ↗

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.

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

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Leipzig, 04289, Germany
Helios Klinikum Wuppertal

Wuppertal, 42283, Germany
Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany
Herzzentrum München

München, 80636, Germany
LMU Klinikum München

München, 81377, Germany
St.-Johannes-Hospital Dortmund

Dortmund, 44137, Germany
Universitätsklinikum Gießen

Giessen, 35392, Germany
Universitätsklinikum Köln

Cologne, 50937, Germany
Universitätsklinikum Tübingen

Tübingen, 72076, Germany
Zentralklinik Bad Berka

Bad Berka, 99437, Germany

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