Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN

Exclusion Criteria

• •1. CTA, MRA, or DSA examination shows that the shape and structure of the unilateral or bilateral renal arteries are not suitable for ablation surgery (renal artery stenosis exceeding 50%, renal artery aneurysm, fibromuscular dysplasia of the renal artery, or the diameter of the main renal artery is less than 3 mm).
• •2. Having only one kidney or having received a kidney transplant.
• •3. Having a history of renal artery interventional treatment or renal denervation surgery.
• •4. Suffering from any condition that may affect the accuracy of blood pressure measurement, such as the upper arm diameter being too large relative to the cuff.
• •5. Secondary hypertension (excluding apnea syndrome).
• •6. Glomerular filtration rate (eGFR) \< 45 mL/min/1.73m² (MDRD formula).
• •7. Having a history of hospitalization due to hypertensive crisis within one year before randomization for enrollment.
• •8. Suffering from type 1 diabetes.
• •9. Suffering from primary pulmonary hypertension.
• •10. Being allergic to contrast agents.
• •11. Severe cardiac valve stenosis.
• •12. Cardiac insufficiency (NYHA class III - IV).
• •13. Hyperthyroidism or hypothyroidism.
• •14. Requiring mechanical ventilation for assisted breathing (except for nocturnal respiratory support for treating sleep apnea).
• •15. Acute or severe systemic infection.
• •16. Having an implantable cardioverter - defibrillator (ICD) or pacemaker.
• •17. Having obvious symptoms of active peptic ulcer (such as abdominal pain, nausea, vomiting, regurgitation, etc.).
• •18. Having obvious bleeding tendency and hematological diseases.
• •19. Having a history of surgery or trauma requiring hospitalization within 30 days before randomization for enrollment.
• •20. Having a cardiovascular event (stable or unstable angina, myocardial infarction) or cerebrovascular event (stroke, cerebrovascular accident, transient ischemic attack) within 6 months before randomization for enrollment.
• •21. Pregnant, lactating women, or women planning to become pregnant during the study period.
• •22. Currently participating in other clinical trials of drugs or medical devices.
• •23. Other reasons that the investigator deems inappropriate for participation in this study