This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.
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 twenty patients who meet the eligibility criteria and have signed the informed consent form. Safety is the primary endpoint of this study. Safety 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 a secondary endpoint of this study. Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System
St. Anne's University Hospital
Brno, Czechia
Nemocnice Na Homolee Hospital
Prague, Czechia
Mercy Angiography
Aukland, New Zealand
Safety
Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through 52-week evaluation. Included in this assessment will be the proportion of subjects with any of the following outcomes: 1) death, or 2) medical morbidity.
Time frame: 52-week post-treatment
Clinical Utility
Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
Time frame: 52-week post-treatment
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