The purpose of Iberis-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with primary hypertension by using Iberis multielectrode renal denervation system
The purpose was to evaluate 3-month outcomes of RDN for the treatment of primary hypertension in Chinese patients.In a prospective, multi-center study, 216 Chinese patients with primary hypertension would be recruited to undergo RDN by Iberis Multielectrode denervation system. The primary effectiveness endpoint wasReduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
216
After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 10 minutes prior to introducer sheath removal.
Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up
Time frame: 3 months
Reduction in average 24-hour ambulatory systolic blood pressue at 6 months
Time frame: 6 months
Change in office systolic blood pressure
Time frame: 1 month,3 months,6 months and 12 months
Device or procedure related acute adverse events
Time frame: 1 month,3 months,6 months and 12 months
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