Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis
Valvosoft First-In-Man 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-man
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. This is a FIM study
Inclusion Criteria:

 1. Subjects suffering from severe symptomatic aortic valve stenosis (including subjects
 with a bicuspid valve).

 2. Patient is not eligible for TAVR/SAVR .

 3. Age ≥18 years.

 4. Subjects who are willing to provide a written informed consent prior to participating
 in the study.

 5. Subjects who can comply with the study follow up or other study requirements.

 6. Subject eligible according to Clinical Review Committee

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 Exclusion Criteria:

 1. Subjects with any electrical device implanted.

 2. Subjects with unstable arrhythmia not controlled by medical treatment.

 3. Subjects with implanted mechanical valve in any position or bio prosthetic valve in
 aortic position.

 4. Subjects with complex congenital heart disease.

 5. Chest deformity.

 6. Cardiogenic shock.

 7. History of heart transplant.

 8. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral
 valve procedure, tricuspid valve procedure) within one month after treatment.

 9. Thrombus in heart.

 10. Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one
 month prior to enrolment*.

 11. Subjects who are pregnant or nursing.

 12. Subjects who are participating in another research study for which the primary
 endpoint has not been reached.

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