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.
Disclaimer
Read more
Show less
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.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for SYMPTOMATIC AORTIC STENOSIS 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
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Locations
-
Tbilisi Heart and Vascular Clinic Ltd
Tbilisi, Georgia