Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis

Status Active, not recruiting

Clinical Trial Summary

This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human

Clinical Trial Description

CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a new ultrasound therapy based on a disruptive technology involving delivering an extremely precise and focused ultrasound beam to perform a reparative effect on the aortic valve leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving the overall clinical status related to the aortic valve stenosis. In this study, a brai-MRI is performed before the procedure and 24-72 hours after the procedure to detect cerebrovascular events.This is a FIM study ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04665596
Study type	Interventional
Source	Cardiawave SA
Contact
Status	Active, not recruiting
Phase	N/A
Start date	December 23, 2019
Completion date	May 15, 2024

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