Heart valve scoring device trial halted after just one patient
NCT ID NCT05052684
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a device called Leaflex™ Performer, which is threaded through a blood vessel to the heart to score and loosen calcium buildup on stiff aortic valves. It was designed for people with severe aortic stenosis who cannot have standard valve surgery or replacement. However, the trial was terminated early after enrolling only one person, so we have very little information about how well it works or its safety.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Leaflex™ Performer (a catheter device that scores calcification in heart valve leaflets)
What this could lead to
If it worked, this device could offer a less invasive treatment option for people with severe aortic stenosis who cannot have standard valve replacement.
What could go wrong
The trial was terminated early with only 1 participant, so results are very limited. The device may not be safe or effective, and risks include stroke, valve damage, or worsening heart function.
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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Instituto do Coração FMUSP Centro de Pesquisa
São Paulo, 05403-000, Brazil