Tests kidney nerve ablation for uncontrolled high blood pressure with chronic kidney disease
Tests a kidney nerve ablation device in people with uncontrolled hypertension and chronic kidney disease.
Plain-language title generated from the registry record
Registry title: A Randomized Trial of Six-Channel RF Ablation System for Renal Denervation in Uncontrolled Hypertension and Chronic Kidney Disease
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07130955, who can take part
Where in China
- Beijing Anzhen Hospital Affiliated to Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Golden Leaf MedTec Co. Ltd
- Trial code
- NCT07130955
- Record updated
- 11 February 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis; Prior renal artery intervention or prior renal denervation; 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; History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker; 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); 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; 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; Acute or severe systemic infection; Other conditions deemed unsuitable for participation by the investigator; 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); 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); Orthostatic hypotension; Severe hepatic dysfunction.