Can a new valve fix a leaky heart without open surgery?

NCT ID NCT07751965

Not yet recruiting Disease control Sponsor: Ceric Sàrl Source: ClinicalTrials.gov ↗

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial is testing whether a new heart valve device, called Myval, can safely and effectively treat people with severe aortic regurgitation—a condition where the heart's aortic valve doesn't close properly, causing blood to leak backward. The study involves about 164 adults who are at high risk for traditional open-heart surgery. Participants will receive the Myval valve through a minimally invasive procedure, and researchers will monitor their outcomes, including survival, stroke, bleeding, and valve function.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Myval transcatheter heart valve (THV) system
What this could lead to: If successful, this could offer a less invasive treatment option for people with severe aortic regurgitation who are too frail for open-heart surgery.
What could go wrong: This is an early-stage, single-arm study without a comparison group, so results may not be definitive. Risks include bleeding, stroke, and the need for a permanent pacemaker.

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 disorder aortic valve calcification aortic valve insufficiency Aortic Valve, Calcification of

As listed by the trial registrant

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

AORTIC DISEASE AORTIC REGURGITATION CALCIFIED AORTIC VALVE

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