New heart valve device shows early promise in small study

NCT ID NCT06510855

First seen May 17, 2026 · Last updated Jun 23, 2026 · Updated 4 times

Summary

This early study is testing a new device called the DurAVR™ THV System, which is a replacement heart valve placed through a small tube in the leg (TAVI procedure). The study includes 40 people with severe aortic stenosis or a failed surgical valve. The main goal is to see if the device is safe and feasible, looking at rates of death or disabling stroke at 30 days.

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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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Contacts and locations

Locations

  • Rigshospitalet

    Copenhagen, Capital Region of Denmark, 2100, Denmark

What this could mean

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

Active substance

DurAVR™ THV System (a replacement heart valve implanted via a catheter)

What this could lead to

If this device works well, it could offer a new, less invasive option for people with severe aortic stenosis who need a valve replacement.

What could go wrong

This is a very early, small study (40 people) focused on safety and feasibility. The device may not work as well as existing valves, and there are risks like bleeding, stroke, or death.

Conditions

The condition(s) this trial relates to.

Aortic Valve Disease aortic valve stenosis Aortic Valve, Calcification of

As listed by the trial registrant

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