Heart valve fix without cutting chest: trial pulled before it began

NCT ID NCT03714412

Terminated Disease control Sponsor: Cardiovalve Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study planned to test a new device called the Cardiovalve, which is threaded through a leg vein to replace a leaky mitral valve in people too sick for open-heart surgery. The trial was withdrawn before any participants were enrolled, so no results are available. The approach aimed to offer a safer alternative for those with severe mitral regurgitation.

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 replacement system (a device implanted via a catheter through a leg vein to replace the mitral valve)
What this could lead to: If successful, this device could offer a less invasive treatment option for people with severe mitral regurgitation who are too frail for open-heart surgery.
What could go wrong: The trial was withdrawn before any patients were enrolled, so no data exist. The device may carry risks like bleeding, valve leakage, or need for repeat procedures.

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.

mitral valve insufficiency

As listed by the trial registrant

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

MITRAL REGURGITATION

Contacts and locations

Locations

Hygeia Hospital

Athens, Greece
Silesian Center for Heart Diseases

Zabrze, 41-800, Poland

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