Experimental heart valve device tested in just one patient — study halted

NCT ID NCT03813524

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

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.

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

Columbia University Medical Center/NYPH

New York, New York, 10032, United States
Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

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