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

The six-channel RF renal denervation system, consisting of the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery radiofrequency denervation.

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• NYHA Class III/IV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months.
• History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.
• Acute kidney injury (AKI) within 4 weeks before enrollment or acute kidney disease ，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).
• Severe hepatic dysfunction.
• Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.
• Known drug or alcohol dependence, difficulty understanding the study protocol, inability or unwillingness to comply with follow-up requirements.
• Current or planned participation in other clinical trials of drugs or medical devices (post-marketing registry studies permitted).
• Acute or severe systemic infection.
• Other conditions deemed unsuitable for participation by the investigator.