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

Exclusion Criteria

• •1. Pregnant or breastfeeding, or planning pregnancy during the study.
• •2. 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).
• •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 unstable 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 ，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).
• •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.