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

NCT ID NCT03714412

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 The trial was withdrawn before any participants were enrolled, so no results are available.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The trial was withdrawn before any patients were enrolled, so no data exist.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.

Disclaimer Read more

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.

mitral valve insufficiency

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hygeia Hospital

    Athens, Greece

  • Silesian Center for Heart Diseases

    Zabrze, 41-800, Poland