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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacemen
Clinical Centre of Serbia
Belgrade, Serbia
Safety: Rate of procedure related mortality
Rate of procedure related mortality at 30 days
Time frame: Up to 30 days
Device performance to modify valve structure as measured by echocardiography
Ability to modify the Left Ventricular Ejection Fraction (%)
Time frame: Immediately after the procedure
Device performance to modify valve structure as measured by echocardiography
Ability to modify the Mean Pressure Gradient (mmHg)
Time frame: Immediately after the procedure
All-cause mortality
Number of patients that die during the course of the study and if so, how long aftre the procedure
Time frame: Up to two years
Rate of stroke
Rate of stroke
Time frame: Up to two years
Change of severity of heart failure
Change of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest)
Time frame: At 1, 3,6,12 and 24 months
Major Adverse Events
Rate of Major Adverse Events (MAE) and number of patients with one or more MAE during the course of the study, an MAE defined as: Disabling stroke, Myocardial infarction or any clinically significant changes in biomarkers (CK, Troponin I - T) that would indicate damage to the heart structure, or clinically significant conduction disturbances requiring pacemaker implantation or persistent arrhythmias
Time frame: Up to 2 years
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Adverse events
Rate of all Adverse Events
Time frame: Up to 2 years
User Handeling
User handling (questionnaire for operator + procedure duration
Time frame: Immediately after the procedure
Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient
Long term maintenance of improvement of AVA and PG
Time frame: At 1, 3, 6,1 2 and 24 months
quality of life measured through Kansas City Cardiomyopathy Questionnaire
Improvement of quality of life by means of KCCQ
Time frame: at 1, 3, 6, 12 and 24 months