This study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy. It will be conducted on a maximum of fifty patients who meet the inclusion and exclusion criteria and have signed the informed consent form. Safety is the primary endpoint of this study and will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation. Clinical utility is the secondary endpoint of this study and will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Monash Medical Center
Melbourne, Australia
St. Paul's Hospital
Vancouver, British Columbia, Canada
St. Anne's University Hospital
Brno, Czechia
Nemocnice Na Homolee Hospital
Prague, Czechia
Safety: Incidence of Adverse Events through 52 week follow-up
Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity, including but not limited to renal artery aneurysm, stenosis, significant deterioration of renal function, fistulae or ureteral stenosis.
Time frame: One Year
Decrease in Blood Pressure
Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.
Time frame: 12 and 24 weeks post therapy
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