New heart valve device shows early promise in small study
NCT ID NCT06510855
First seen Jun 27, 2026 · Last updated Jun 27, 2026
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.
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.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Rigshospitalet
Copenhagen, Capital Region of Denmark, 2100, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a fitness app boost recovery after heart valve replacement?
- Can a Patient's other health problems predict how well a new aortic valve performs?
- Can a single antiplatelet drug beat aspirin after heart valve replacement?
- Blood test could predict clot risk after heart valve surgery
- Could a lower warfarin dose make aortic valve replacement safer?
- Lab and body tests aim to find best heart valve for small aortic openings