Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN

Prospective, multicenter, randomized, controlled, blinded, and superiority - designed; The target population undergoes a screening treatment with prescribed medications for at least 4 weeks. Eligible subjects are randomly assigned to the experimental group and the control group at a ratio of 2:1. The experimental group is treated with the ultrasound nerve ablation catheter and the ultrasound nerve ablation device of Shenzhen Maiwei Medical Technology Co., Ltd., while the control group only undergoes renal arteriography (regarded as a sham operation). Within 6 months after the operation, both groups continue to receive antihypertensive drug treatment with the dosage and types specified during the screening period. The subjects are kept blinded during the study. The relative change values of the average 24 - hour ambulatory systolic blood pressure from the baseline at 6 months after the operation are compared between the two groups.

NCT Number	NCT06877221
Lead Sponsor	Shenzhen Pulsecare Medical Technology Co., Ltd.
Conditions	Refractory Hypertension or Drug-intolerant Hypertension
Enrollment	204 participants
Start Date	2025-01-25
Primary Completion	2027-12 (estimated)
Study Completion	2030-12 (estimated)
Updated on ClinicalTrials.gov	2025-06-19