CompletedNo phase
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
Key facts
- Who runs it
- Cardiawave SA
- Where
- Serbia1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 10 people enrolled
- Started
- 23 Dec 2019
- Ended
- 23 May 2024
- Type of study
- Interventional
- Treatments tested
- Ultrasound treatment
- Record updated
- 20 August 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Subjects suffering from severe symptomatic aortic valve stenosis according to ESC 2017 definition, including subjects with a bicuspid valve
- Patient is not eligible for TAVR/SAVR according to local Heart Team
- Age ≥18 years
- Subjects who are willing to provide a written informed consent prior to participating in the study
- Subjects who can comply with the study follow up or other study requirements
- Patient is eligible for the Valvosoft procedure according to CRC
Who cannot take part
- Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment*
- Subjects with unstable arrhythmia not controlled by medical treatment
- Subjects with complex congenital heart disease
- History of heart transplant
- Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment
- Thrombus in heart
- Subjects with any electrical device implanted
- Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position
- Chest deformity
- Cardiogenic shock
- Subjects who are pregnant or nursing
- Subjects who are participating in another research study for which the primary endpoint has not been reached
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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
The group in the trial
- Ultrasound treatmentTreatment being tested
Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 20 August 2024