New heart valve trial hopes to offer less invasive option for aortic stenosis patients

NCT ID NCT05804903

Terminated Disease control Sponsor: NVT GmbH Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing a new device called the ALLEGRA Plus Transcatheter Heart Valve in 177 people with severe aortic stenosis or a failed surgical valve. The valve is implanted through a catheter, avoiding open-heart surgery. Researchers are checking how safe and effective it is over 12 months, focusing on death and stroke rates.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ALLEGRA Plus Transcatheter Heart Valve (a device implanted via a catheter to replace the aortic valve)
What this could lead to: If successful, this could provide a less invasive treatment option for people with severe aortic stenosis or a failed surgical valve, potentially improving survival and reducing stroke risk.
What could go wrong: The trial is currently suspended, and it is an early-stage study with only 177 participants. Risks include complications from the procedure, such as stroke or death, and the device may not perform as well as expected.

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.

TRANSCATHETER AORTIC VALVE IMPLANTATION

Contacts and locations

Locations

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany
Herzzentrum - Luzerner Kantonsspital

Lucerne, 6000, Switzerland
Hospital La Paz

Madrid, 28046, Spain
III Katedra Kardiologii

Katowice, 40-635, Poland
Klinika Kardiochirurgii

Gdansk, 80-214, Poland
Oulu University Hospital

Oulu, 90220, Finland
Reina Sofia Hospital

Córdoba, 14004, Spain

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