Status:
COMPLETED
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
Lead Sponsor:
Cardiawave SA
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Subjects with any electrical device implanted.
- Subjects with unstable arrhythmia not controlled by medical treatment.
- Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
- Subjects with complex congenital heart disease.
- Chest deformity.
- Cardiogenic shock.
- 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.
- Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment\*.
- Subjects who are pregnant or nursing.
- Subjects who are participating in another research study for which the primary endpoint has not been reached.
Key Trial Info
Start Date :
December 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04665596
Start Date
December 23 2019
End Date
May 23 2024
Last Update
August 20 2024
Active Locations (1)
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1
Clinical Centre of Serbia
Belgrade, Serbia, 11000