New heart valve device tested in humans for first time
NCT ID NCT05182307
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device called the DurAVR™ THV System, a replacement heart valve placed through a small tube in an artery, for people with severe aortic stenosis (a narrowed heart valve). The trial involves 150 participants and aims to see if the device is safe and works well. It is the first time this valve is being tested in humans.
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 successful, this could offer a new, less invasive treatment option for people with severe aortic stenosis, potentially improving heart function and survival.
- What could go wrong
- This is a very early, first-in-human study with only 150 participants. The device may not work as expected, and risks include bleeding, stroke, or heart attack. Long-term benefits are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for AORTIC VALVE CALCIFICATION are added.
By submitting, you agree to our Terms of use
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
-
Tbilisi Heart and Vascular Clinic Ltd
Tbilisi, Georgia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a single antiplatelet drug beat aspirin after heart valve replacement?
- Lab and body tests aim to find best heart valve for small aortic openings
- Can immune and imaging clues predict heart valve disease progression?
- Heart valve mystery: scientists hunt for genetic clues in 1,000 patients
- CT scan could guide safer blood thinner use after TAVI
- New heart valve device shows early promise in small study