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

NCT07130955 | Enrolling By Invitation

• 1 other identifier: MLWY-S20250422
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Uncontrolled Hypertension; CKD; RDN

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in 24-hour Ambulatory Systolic Blood Pressure at Month 6 (ABPM)

  24-hour mean systolic BP measured by validated ambulatory BP monitoring; change is Month 6 minus Baseline.

  Baseline to Month 6 post-procedure

Secondary Outcomes (13)

• Change from Baseline in 24-hour Ambulatory Diastolic Blood Pressure at Month 6 (ABPM)

  Baseline to Month 6 post-procedure

• Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)

  Baseline to Months 1, 3, 12, 24, and 36 post-procedure

• Change from Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure (ABPM)

  Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure

• Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)

  Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure

• Percentage of Participants with 24-hour Ambulatory Systolic BP <130 mmHg

  Months 1, 3, 6, 12, 24, and 36 post-procedure

Study Arms (2)

Renal Denervation (RDN)

EXPERIMENTAL

Participants receive percutaneous renal sympathetic denervation under digital subtraction angiography (DSA) guidance using a six-channel radiofrequency generator(model 25D1G, software release SRG-V1) and ultra-guiding radiofrequency denervation catheter (model 25C6W127F115T) manufactured by Shanghai Golden Leaf MedTec Co., Ltd(BRATTEA). All participants receive a standardized antihypertensive regimen for ≥4 weeks before the procedure and thereafter per protocol. Follow-up visits occur at 7 days or before discharge, and at 1, 3, 6, 12, 24, and 36 months. Assigned Interventions: Device: Six-channel RF Renal Denervation System; Drug: Standardized Antihypertensive Therapy

Device: Six-channel RF Renal Denervation System

Parallel control with sham operation

SHAM COMPARATOR

Participants undergo a sham procedure: femoral artery puncture and selective renal angiography under DSA guidance are performed. The RF generator is connected to a dummy load, and activation sounds are emitted, but no energy is delivered. Participants remain on the procedure table for at least 35 minutes before sheath removal. Background standardized antihypertensive therapy is provided for ≥4 weeks pre-procedure and continued per protocol. Follow-up visits occur at 7 days or before discharge, and at 1, 3, 6, and 12 months. After completing the 6-month visit, participants may transition to active RDN and then be followed up to 36 months; those declining crossover will continue follow-up at 12，24 and 36 months. Assigned Interventions: Procedure: Sham operation; Drug: Standardized Antihypertensive Therapy

Procedure: Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)

Interventions

Six-channel RF Renal Denervation System DEVICE

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)

Renal Denervation (RDN)

Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation) PROCEDURE

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.

Parallel control with sham operation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18 to 65 years, inclusive, at the time of consent;
• Hypertensive subjects who have been taking 2 types of standardized antihypertensive drugs continuously and stably for at least 4 weeks, with office systolic blood pressure still ≥150 mmHg and \<180 mmHg, and 24-hour ambulatory mean systolic blood pressure (24h SBP) ≥135 mmHg and \<170 mmHg; or who have been taking ≥3 types of standardized antihypertensive drugs continuously and stably for at least 4 weeks, with office systolic blood pressure ≥140 mmHg and \<180 mmHg, and 24h SBP ≥130 mmHg and \<170 mmHg;
• Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73m² and \<60 mL/min/1.73m²;
• The subject or his/her legal representative fully understands the content of the informed consent form for this trial and voluntarily signs the written informed consent form.

You may not qualify if:

• Pregnant or breastfeeding, or planning pregnancy during the study.
• Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter \<3 mm, or treatable segment length \<20 mm).
• Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis.
• Prior renal artery intervention or prior renal denervation.
• Other secondary hypertension not related to kidney disease (such as primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).
• Allergic to contrast agents.
• Major surgery or trauma within 1 month before enrollment; acute coronary syndrome within 6 months; or planned surgery or cardiovascular interventional therapy within the next 6 months.
• Orthostatic hypotension.
• Type 1 diabetes mellitus.
• Primary pulmonary arterial hypertension.
• History of bleeding diathesis and haematological disorders or coagulopathy
• History of thromboembolic event within 6 months.
• History of stroke or transient ischemic attack (TIA) within 6 months.
• Severe peripheral arterial disease or unstable abdominal aortic aneurysm.
• Severe valvular heart disease or anticipated need for surgical valve replacement during the study period.

Sponsors & Collaborators

• Beijing Anzhen Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• West China Hospital: collaborator
• Shanghai Golden Leaf MedTec Co. Ltd: lead
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Jiangxi Provincial People's Hopital: collaborator
• Navy General Hospital, Beijing: collaborator
• Qilu Hospital of Shandong University: collaborator
• Xijing Hospital: collaborator
• Fujian Provincial Hospital: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator
• Henan Provincial People's Hospital: collaborator
• Hebei Provincial People's Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Qianfoshan Hospital: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Mianyang Central Hospital: collaborator
• The Third People's Hospital of Chengdu: collaborator
• General Hospital of the Eastern Theater Command: collaborator
• China-Japan Union Hospital, Jilin University: collaborator
• Shanxi Bethune Hospital: collaborator
• Second Hospital of Shanxi Medical University: collaborator
• Yan'an Affiliated Hospital of Kunming Medical University: collaborator

Study Sites (1)

Beijing Anzhen Hospital, affiliated to Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The trial will enroll 236 subjects (trial group: control group = 1:1)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Multicenter, Randomized, Parallel-Controlled,The trial will enroll 236 subjects (trial group: control group = 1:1).

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 19, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): September 30, 2030
• Last Updated: February 11, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)