Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
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
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
Inclusion Criteria:

 -  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 Criteria:

 -  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.