The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Na Homolce Hospital
Prague, Czechia
RECRUITINGMajor adverse events
All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure
Time frame: 30 days
Change from baseline in office blood pressure measurement
Time frame: 30 days, 3 months, 6 months, 9 months, 12 months
Change from baseline in ambulatory 24-hour blood pressure measurement
Time frame: 6 months, 12 months
Change from baseline in renal artery dimensions
Change in renal artery dimensions as measured by renal angiography, CT, or MRI
Time frame: 30 days
Change from baseline in creatinine
Time frame: 6 months
Adverse events and device complications
Time frame: 12 months
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