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New heart valve and simpler procedure could change aortic stenosis treatment

NCT ID NCT05036018

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

836 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Feb 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Severe symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indication for transcatheter aortic valve implantation according to heart team consensus * Perimeter-derived native aortic valve annulus diameter measuring 21-27 mm * Heart team consensus that the patient is anatomically suitable for both device types * Suitability for transfemoral vascular access * Written informed consent Exclusion Criteria: * Life expectancy \<12 months due to comorbidities * Native aortic valve annulus \<21 mm and \>27 mm * Bicuspid aortic valve * Cardiogenic shock or hemodynamic instability * Active endocarditis * Contraindications for transfemoral access * Active peptic ulcer or upper gastro-intestinal bleeding \<2 weeks * Hypersensitivity or contraindication to aspirin, heparin or clopidogrel * Contraindication for a specific treatment strategy (minimalist approach vs. standard of care) as judged by the Heart Team * Clear patient-specific clinical or anatomic reasons to prefer one treatment strategy or valve type over the other * Active infection requiring antibiotic treatment * Age \<18 years * Participation in another interventional trial where the primary endpoint has not been reached

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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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