Prospective, Multi-Center, Randomized, shame-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radio-frequency(RF) renal denervation system-comprising the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
DSA-guided percutaneous renal sympathetic denervation using a six-channel RF renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)
Sham procedure including femoral artery puncture and selective renal angiography; the six-channel radiofrequency generator is connected to a dummy load and produces activation sounds, but no energy is delivered. Minimum table time before sheath removal is 35 minutes.
Change in 24-h ambulatory BP at 3 months post-procedure compared between the 2 groups.
the change in 24-h ambulatory systolic/diastolic BP at 3 months post-procedure compared between the 2 groups.
Time frame: 3 months
Change from Baseline in Daytime and Nighttime Ambulatory Systolic /diastolic Blood Pressure (ABPM)
24-hour mean systolic /diastolic BP measured by validated ambulatory BP monitoring;
Time frame: Baseline to 3 Months
Percentage of Participants with 24-hour Ambulatory BP <130 /80 mmHg
24-hour mean BP measured by validated ambulatory BP monitoring;
Time frame: Months 3 post-procedure
Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)
measured by validated office blood pressure monitoring
Time frame: Baseline to Months 3 post-procedure
Change from Baseline in Antihypertensive Medication Use
Change in the number of concurrently prescribed antihypertensive agents
Time frame: Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 3 post-procedure
change from baseline in the time in target range of 24 hour ambulatory blood pressure
24-hour mean BP measured by validated ambulatory BP monitoring;
Time frame: Months 3 post-procedure
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