The objective of the study is to evaluate the safety of renal denervation using the iRF System and to understand any potential improvement in hypertension.
This study is a prospective, single-arm, multi-center, non-randomized trial to evaluate the initial safety and performance of renal denervation with the iRF system for the treatment of hypertension.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
30
The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the artery
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
Rate of Major Adverse Events
Incidence of the following Major Adverse Events (MAEs) * Death (all-cause) * New onset end stage renal disease * Significant embolic events resulting in end-organ damage * Renal artery perforation or dissection requiring intervention * Hospital admission for hypertensive crisis not related to confirmed non-adherence with medications or protocol * New renal stenosis \> 70 %
Time frame: Index Procedure through 30 days
Change in Systolic/Diastolic Blood Pressure - Average Automated Office Blood Pressure
Change from baseline in systolic/diastolic blood pressure as indicated by average automated office blood pressure
Time frame: Time Frame: 30, 90, 180 and 365 days
Change in Systolic/Diastolic Blood Pressure - Ambulatory Blood Pressure Monitoring
Change from baseline in systolic/diastolic blood pressure as indicated by ambulatory blood pressure monitoring
Time frame: Time Frame: 90, 180 and 365 days
Effects on renal function assessed with glomerular filtration rate
Change from baseline in renal function as indicated by eGFR
Time frame: Time Frame: 30, 90, 180 and 365 days
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