Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study

The six-channel RF renal denervation system, consisting of the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery RF denervation. This Prospective, Multi-Center, Randomized, shame-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines, and to provide clinical evidence supporting the expansion of indications. The trial will be conducted by the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration and Filing, the Good Clinical Practice for Medical Devices, and other applicable requirements.