New heart valve mimics nature to improve blood flow in major trial

NCT ID NCT07194265

Recruiting now Disease control Sponsor: Anteris Technologies Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 16, 2026 · Updated 7 times

Summary

This study compares a new heart valve, the DurAVR®, to standard TAVR valves in up to 1650 people with severe aortic stenosis. The valve is designed to mimic natural blood flow. Participants are randomly assigned to get the new valve or a standard one and are followed for up to 10 years. The goal is to see if the DurAVR® is safer and works better.

What this could mean

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

Active substance: DurAVR® biomimetic heart valve (a device for transcatheter aortic valve replacement)
What this could lead to: If it works, this could offer a more natural blood flow and better outcomes for people needing a new heart valve without open-heart surgery.
What could go wrong: This is a large, randomized trial, but the new valve may not prove safer or more effective than existing valves. Risks include stroke, bleeding, or valve failure over time.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Aortic Valve, Calcification of

As listed by the trial registrant

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

SEVERE AORTIC STENOSIS VALVE-IN-VALVE PROCEDURES

Contacts and locations

Locations

Rigshospitalet
RECRUITING

Copenhagen, Capital Region of Denmark, 2100, Denmark

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