NCT05235568

VALVOSOFT® Pivotal Study

Prospective, Single-arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cardiawave SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis

Conditions

• Aortic Valve Calcification
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	VALVOSFT intervention	Treatment of the calcific aorta valve by non-invasive ultrasound therapy

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-08-17
• Completion: 2024-07-24
• First posted: 2022-02-11
• Last updated: 2024-08-20

Locations

11 sites across 3 countries: France, Germany, Netherlands