NCT06650839

POC for the Treatment of Subjects With Moderate AS Using Valvosoft® Non-Invasive Ultrasound Therapy

Proof of Concept Clinical Investigation for the Treatment of Subjects With Moderate Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cardiawave SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy.

Detailed description

Valvosoft, Ultrasound guided Non-Invasive Ultrasound Therapy (NIUT) medical device, delivers focused and controlled, short ultrasound pulses (\<20μsec), directed trans-thoracically at a high acoustic intensity (measured in watts per square centimeter (W/cm2), to produce non-thermal mechanical tissue softening of the targeted calcified aortic valve. Echocardiographic live imaging enables to follow valve movements in real-time and thus target the therapeutic ultrasound on the calcified valve with great precision. This is first in human or proof of concept study.

Conditions

• Moderate Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	NIUT	Treatment of moderate aortic stenosis using non-invasive ultrasound therapy delivered by Valvosoft

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-01
• Completion: 2027-12-01
• First posted: 2024-10-21
• Last updated: 2026-01-07

Locations

1 site across 1 country: Serbia