Tiny trial tests new valve for patients too sick for Open-Heart surgery
NCT ID NCT03958773
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study is testing a new device called the Cardiovalve system in 10 people with severe mitral regurgitation (a leaky heart valve) who are at high risk for open-heart surgery. The valve is delivered through a vein in the leg, avoiding a large chest incision. The main goal is to check for serious complications, not yet to prove the device works long-term.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Cardiovalve transfemoral mitral valve system (a replacement heart valve delivered through a leg vein)
What this could lead to
If it works, this could offer a safer option for people with severe mitral regurgitation who are too frail for open-heart surgery.
What could go wrong
This is a very small early feasibility study with only 10 participants. The device may cause serious complications like kidney injury, heart failure, or need for repeat surgery. Success is not guaranteed.
Disclaimer
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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.
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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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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Hospital of the Lithuanian University of Health Sciences ligoninė Kauno
Kaunas, Lithuania