A new heart valve without Open-Heart surgery: can it help High-Risk patients?

NCT ID NCT07734025

Not yet recruiting Disease control Sponsor: Onecrea Medical Inc. Source: ClinicalTrials.gov ↗

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial is testing a new device called the Crea Aortic Valve, a replacement heart valve that can be implanted through a catheter without open-heart surgery. It is designed for people aged 60 and older with severe aortic stenosis—a narrowing of the heart's main valve—who are considered too high-risk for traditional surgery. The study will measure how safely and effectively the valve works, and whether it improves patients' symptoms and quality of life.

What this could mean

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

Active substance: an investigational transcatheter aortic valve replacement system called the Crea Aortic Valve
What this could lead to: If successful, this could offer a new, less invasive option for replacing a narrowed aortic heart valve in patients who are too frail for open-heart surgery.
What could go wrong: This is an early-stage study with only 30 participants, so results may not apply to everyone. As with any heart valve procedure, risks include stroke, bleeding, and valve dysfunction.

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 SEVERE AORTIC STENOSIS

More trials for these conditions

Other studies related to the condition(s) this trial covers.