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Sound waves instead of surgery: new device aims to soften stiff heart valves

NCT ID NCT07520591

Not yet recruiting Disease control Sponsor: Cardiawave SA Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry will follow 200 people with severe aortic valve stenosis who receive a non-invasive ultrasound therapy called Valvosoft. The treatment uses focused sound waves to soften calcium buildup on the valve without surgery. Researchers will track safety and effectiveness for 12 months after the procedure.

What this could mean

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

Active substance
non-invasive ultrasound therapy (Valvosoft device)
What this could lead to
If successful, this could offer a non-surgical option for people with severe aortic stenosis who cannot have or refuse valve replacement surgery.
What could go wrong
This is an early post-market registry with no control group, so results may not prove the therapy works better than alternatives. Risks include potential heart complications from the procedure.

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 calcification Aortic Valve Disease aortic valve disorder aortic valve stenosis Aortic Valve, Calcification of heart failure

As listed by the trial registrant

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

AORTIC STENOSIS, SEVERE AORTIC VALVE CALCIFICATION AORTIC VALVE DISEASE HEART FAILURE ULTRASOUND THERAPY

Contacts and locations

Locations

  • CHU Rouen Hopital Charles Nicolle

    Rouen, France

  • Hopital Bichat

    Paris, France

  • Hopital Europeen Georges Pompidou

    Paris, France

  • Marienkrankenhaus

    Hamburg, Germany

  • RadboudUMC

    Nijmegen, Netherlands

  • University Hospital Schleswig Holstein Campus Kiel

    Kiel, Germany

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