A Randomized Trial of Six-Channel RF Ablation System for Renal Denervation in Uncontrolled Hypertension and Chronic Kidney Disease

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.

Conditions

• Hypertension
• CKD - Chronic Kidney Disease

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.

Sponsors & Collaborators

• Beijing Anzhen Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Jiangxi Provincial People's Hopital

  collaborator OTHER

• Navy General Hospital, Beijing

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• Fujian Provincial Hospital

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Hebei Provincial People's Hospital

  collaborator UNKNOWN

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• The First Hospital of Jilin University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Qianfoshan Hospital

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• Mianyang Central Hospital

  collaborator OTHER

• The Third People's Hospital of Chengdu

  collaborator OTHER

• General Hospital of the Eastern Theater Command

  collaborator UNKNOWN

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• Shanxi Bethune Hospital

  collaborator OTHER

• Second Hospital of Shanxi Medical University

  collaborator OTHER

• Yan'an Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Shanghai Golden Leaf MedTec Co. Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-08

Primary Completion

2026-12-30

Completion

2030-09-30

Countries

• China

Study Locations