The aim of the study is to assess the safety and effectiveness of a novel device for renal denervation to lower blood pressure in people with uncontrolled hypertension. Prior studies demonstrate the potential benefit of renal denervation in hypertension, though these studies primarily denervate the kidneys by passing catheters through the arteries in the groin into the renal arteries. The TUSK study utilizes the Phoenix system to perform denervation by advancing the device (a thin electrode) through the urinary tract into the kidneys where radiofrequency energy is briefly applied to denervate the kidneys.
Up to 20 patients with uncontrolled hypertension will be treated with the PhoenixTM renal pelvic denervation system, whether or not receiving background medical therapy. Qualification will be based on documented uncontrolled hypertension by 24-hour ambulatory blood pressure monitoring. Those qualifying will be expected to maintain their medical therapy without changes until after the primary effectiveness assessment two months later. Following baseline testing, patients will undergo renal pelvic denervation under anesthesia and remain in the hospital overnight. The denervation device is inserted through the urethra into each kidney and all devices are removed at the completion of the procedure. Radiofrequency energy is administered for a single 2-minute treatment period in each kidney. Follow up visits will extend to one year. Patients will complete medication logs along with repeat assessment of blood pressure in office and via 24-hour ambulatory blood pressure monitor. Follow up testing will also include imaging studies of the kidneys.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Using the natural orifice of the urethra, the ureters are accessed (bilaterally and in sequence), to allow for an ablation device to be placed into the renal pelvis where RF energy is delivered to ablate renal nerves.
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
Pineo Medical Ecosystem
Tbilisi, Georgia
Change in mean daytime systolic blood pressure
Mean daytime systolic blood pressure determined from ambulatory blood pressure monitoring
Time frame: Month 2
Change in mean 24-hour systolic blood pressure
Mean 24-hour systolic blood pressure determined from ambulatory blood pressure monitoring
Time frame: Month 2
Change in automated office systolic blood pressure
Automated office blood pressure measured after resting and in triplicate
Time frame: Month 2
Safety of renal pelvic denervation
Number of subjects with serious adverse events, treatment-emergent adverse events and adverse events assessed, including evidence for acute kidney injury and hypertension-related morbidity
Time frame: Month 2
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