NCT06877221

Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN

A Prospective, Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Effectiveness and Safety of an Ultrasound Renal Denervation Catheter in Combination With an Ultrasound Renal Denervation Device for the Treatment of Refractory Hypertension or Drug - Intolerant Hypertension

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Shenzhen Pulsecare Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Refractory Hypertension or Drug-intolerant Hypertension

Interventions

Type	Name	Description
PROCEDURE	ultrasound renal denervation	Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device

Timeline

• Start date: 2025-01-25
• Primary completion: 2027-12-01
• Completion: 2030-12-01
• First posted: 2025-03-14
• Last updated: 2025-06-19

Locations

1 site across 1 country: China