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A Randomized Trial of Six-Channel RF Ablation System for Renal Denervation in Uncontrolled Hypertension and Chronic Kidney Disease
Sponsor: Shanghai Golden Leaf MedTec Co. Ltd
Summary
Prospective, Multi-Center, Randomized, Parallel-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radiofrequency(RF) renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with uncontrolled hypertension and chronic kidney disease.
Official title: To Evaluate the Efficacy and Safety of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Uncontrolled Hypertension Combined With Chronic Kidney Disease
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2025-08-08
Completion Date
2030-09-30
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Six-channel RF Renal Denervation System
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)
Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)
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.
Locations (1)
Beijing Anzhen Hospital, affiliated to Capital Medical University
Beijing, Beijing Municipality, China