Heart valve scoring device trial halted after just one patient

NCT ID NCT05052684

Terminated Disease control Sponsor: Pi-cardia Source: ClinicalTrials.gov ↗

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.

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.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AORTIC VALVE STENOSIS

Contacts and locations

Locations

Instituto do Coração FMUSP Centro de Pesquisa

São Paulo, 05403-000, Brazil

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