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ENROLLING BY INVITATION
NCT07130955
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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)

PROCEDURE

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