Experimental heart valve device tested in just one patient — study halted
NCT ID NCT03813524
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested a new device called the Cardiovalve Transfemoral Mitral Valve System in just one person with severe mitral regurgitation who was too high-risk for surgery. The device is inserted through a vein in the leg to replace the faulty mitral valve without open-heart surgery. The study aimed to check safety and how well the device works, but it was terminated early, so we have very little data.
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 (a device implanted via a vein to replace the mitral valve)
What this could lead to
If it works, this could offer a less invasive option for people with severe mitral regurgitation who are too high-risk for open-heart surgery.
What could go wrong
This was a very early feasibility study with only 1 participant and was terminated, so results are extremely limited. The device may not be safe or effective in a larger group.
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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Columbia University Medical Center/NYPH
New York, New York, 10032, United States
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Piedmont Heart Institute
Atlanta, Georgia, 30309, United States