New heart valve device tested in early trial
NCT ID NCT07450911
First seen Jun 24, 2026 · Last updated Jul 10, 2026 · Updated 4 times
Summary
This early study is testing a new device called the ReValve System to replace the mitral valve in people with severe mitral regurgitation (a leaky heart valve). The trial will enroll 20 people who are eligible for mitral valve surgery. The main goal is to see if the device can be delivered successfully and reduce the leak.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- ReValve System (mitral valve replacement device)
- What this could lead to
- If successful, this could offer a new treatment option for people with severe mitral regurgitation who need valve replacement.
- What could go wrong
- This is a very early, small trial (20 people) testing safety and technical success. The device may not work as expected or could cause complications.
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
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Locations
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Healthycore
RECRUITINGTbilisi, Georgia
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Tbilisi Heart and Vascular Center
RECRUITINGTbilisi, Georgia
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Tiblisi Heart Center
RECRUITINGTbilisi, Georgia
Contact Phone: •••-•••-•••• Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New heart valve device could spare High-Risk patients from Open-Heart surgery
- First-in-Human trial aims to offer new hope for patients with leaky heart valves who Can't have surgery
- Wireless sensor could help doctors Fine-Tune heart failure treatment in real time
- Tiny device could fix leaky heart valves without cutting chest open
- Artificial intelligence could make heart valve surgery safer and more precise
- Experimental heart valve device tested in just one patient — study halted