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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement
Hôpital Européen Georges Pompidou
Paris, France
Amphia Hospital
Breda, Netherlands
Safety: Rate of procedure related mortality at 30 days
Rate of procedure related mortality at 30 days
Time frame: 30 days post-procedure
Device performance to modify valve structure as measured by echocardiography
Ability to modify the Aortic Valve Area (mm2)
Time frame: Immediately post-procedure
Device performance to modify valve structure as measured by echocardiography
Ability to modify the Pressure Gradient (mmHg)
Time frame: Immediately post-procedure
All-cause mortality and major adverse events (MAE's)
Rate of all-cause mortality and MAE's peri and postprocedure and at 1, 3, 6, 12 and 24 months post operatively.
Time frame: Up to 24 months
Non-disabling stroke
Rate of stroke at 1,3,6, 12 and 24 months
Time frame: Up to 24 months
Improvement of clinical status
Improvement of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest) at 1,3,6,12, and 24 months.
Time frame: Up to 24 months
Number of all Adverse Events (AEs)
Rate of AE's reported at at 1, 3, 6, 12 and 24 months
Time frame: Up to 24 months
User handeling of Valvosoft
User handling (questionnaire for operator + procedure duration) immediately post-procedure
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Time frame: Immediately post-procedure
Improvement of quality of life
Improvement of quality of life by means of Kansas City Cardiomyopathy Questionnaire at 1, 3, 6, 12 and 24 months
Time frame: upto 24 months
Long term maintenance of improvement of AVA and PG
Long term maintenance of improvement of AVA and PG at 3, 6, 12 and 24 months
Time frame: upto 24 months