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 Read more

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.

aortic valve stenosis

As listed by the trial registrant

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

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