The Effectiveness and Safety of the Ultrasonic Nerve Ablation Catheter Used in Conjunction With the Ultrasonic Nerve Ablation Device for the Treatment of Refractory Hypertension or Hypertension in Patients With Drug Intolerance

Launched by WANG PAN · Mar 10, 2025

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 70 years old (calculated based on the date of starting standardized medication).
• • 2. After treatment with at least two types of antihypertensive drugs for 4 weeks or more, the clinic systolic blood pressure is ≥140 mmHg and ≤180 mmHg, and the average 24 - hour ambulatory systolic blood pressure is ≥130 mmHg (or the daytime ambulatory systolic blood pressure is ≥135 mmHg).
• • 3. Resting heart rate ≥70 beats per minute without taking beta - blockers (this criterion does not apply to patients taking beta - blockers).
• • 4. The subject agrees to participate in this clinical trial, complies with the follow - up required by the trial protocol, and has voluntarily signed the informed consent form
• 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