A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Six-Channel Radiofrequency Ablation System Used in Renal Denervation for Treating Patients With Uncontrolled Hypertension and Chronic Kidney Disease
NCT ID: NCT07130955
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
330 participants
INTERVENTIONAL
2025-08-08
2030-09-30
Brief Summary
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Detailed Description
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This Prospective, Multi-Center, Randomized, parallel-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with uncontrolled hypertension and chronic kidney disease, 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Renal Denervation (RDN)
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
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 control with sham operation
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 12-month visit, participants may transition to active RDN and then be followed up to 36 months; those declining crossover will continue follow-up at 24 and 36 months.
Assigned Interventions: Procedure: Sham operation; Drug: Standardized Antihypertensive Therapy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73m² and \<60 mL/min/1.73m²;
4. 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.
Exclusion Criteria
2. Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter \<4 mm, or treatable segment length \<20 mm).
3. Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis.
4. Prior renal artery intervention or prior renal denervation.
5. 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.).
6. Allergic to contrast agents.
7. 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.
8. Orthostatic hypotension.
9. Type 1 diabetes mellitus.
10. Primary pulmonary arterial hypertension.
11. History of bleeding diathesis and haematological disorders or coagulopathy
12. History of thromboembolic event within 6 months.
13. History of stroke or transient ischemic attack (TIA) within 6 months.
14. Severe peripheral arterial disease or abdominal aortic aneurysm.
15. Severe valvular heart disease or anticipated need for surgical valve replacement during the study period.
16. NYHA Class III/IV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months.
17. History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.
18. Acute kidney injury (AKI) within 4 weeks before enrollment or acute kidney disease (AKD) within 3 months before enrollment, defined as:
① AKI: ≥50% increase in serum creatinine within 7 days, or absolute increase ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours, or oliguria (\<0.5 mL·kg-¹·h-¹ for ≥6 hours),
②AKD: AKI; or eGFR \<60 mL/min/1.73 m² for \<3 months; or eGFR decline ≥35% or serum creatinine increase \>50% for \<3 months.
19. Severe hepatic dysfunction.
20. Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.
21. Known drug or alcohol dependence, difficulty understanding the study protocol, inability or unwillingness to comply with follow-up requirements.
22. Current or planned participation in other clinical trials of drugs or medical devices (post-marketing registry studies permitted).
23. Acute or severe systemic infection.
24. Other conditions deemed unsuitable for participation by the investigator.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Golden Leaf MedTec Co. Ltd
INDUSTRY
Beijing Anzhen Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
West China Hospital
OTHER
Jiangxi Provincial People's Hopital
OTHER
Navy General Hospital, Beijing
OTHER
Qilu Hospital of Shandong University
OTHER
Xijing Hospital
OTHER
Fujian Provincial Hospital
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Henan Provincial People's Hospital
OTHER
Hebei Provincial People's Hospital
UNKNOWN
Anhui Provincial Hospital
OTHER_GOV
The First Hospital of Jilin University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Qianfoshan Hospital
OTHER
Ningbo Medical Center Lihuili Hospital
OTHER_GOV
Mianyang Central Hospital
OTHER
Xi'an International Medical Center Hospital
OTHER
Responsible Party
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Locations
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Beijing Anzhen Hospital, affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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MLWY-S20250422
Identifier Type: -
Identifier Source: org_study_id
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