Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN（FIM）

NCT ID: NCT06877234

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-08
• Study Completion Date: 2026-03-31

Brief Summary

This study is a prospective and exploratory clinical study, enrolling patients with essential hypertension. This study is planned to be conducted in 2 research institutions in China, and a total of 6 subjects are planned to be included. After the subjects sign the informed consent form (ICF) approved by the ethics committee, they will enter the screening procedure. Subjects who meet the inclusion criteria and do not meet any of the clinical exclusion criteria will be enrolled after undergoing renal artery CTA angiography.

All patients will undergo clinical evaluation and blood pressure measurement during the operation, at the time of discharge, and at 1 month, 2 months, 3 months, and 6 months after the operation.

It is recommended that the anti-hypertensive medications used before the operation should not be changed within 6 months after the operation for the cases. When the systolic blood pressure (SBP) is ≥ 180 mmHg or there are clinical symptoms caused by hypertension, the drug dosage should be increased as a priority, and then the anti-hypertensive medications should be adjusted. When the systolic blood pressure (SBP) is ≤ 120 mmHg or there are clinical symptoms caused by a decrease in blood pressure, the anti-hypertensive medications should be reduced.

Conditions

Essential Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exploratory Clinical Study of the Ultrasound Nerve Ablation System

Group Type: EXPERIMENTAL

Ultrasonic Nerve Ablation System

Intervention Type: PROCEDURE

Treatment of patients with essential hypertension using the ultrasonic nerve ablation system

Interventions

Ultrasonic Nerve Ablation System

Treatment of patients with essential hypertension using the ultrasonic nerve ablation system

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Males or females aged 18 years old or above and 65 years old or below; Patients with essential hypertension; Patients who have been stably taking 2 or more antihypertensive drugs at conventional doses continuously for at least 4 weeks before enrollment, and whose blood pressure meets the following conditions: (1) The systolic blood pressure measured in the outpatient clinic is ≥150 mmHg and ≤180 mmHg, and the diastolic blood pressure measured in the outpatient clinic is ≥90 mmHg; (2) The systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) is between 135 mmHg and 170 mmHg; The course of hypertension is more than 6 months; The diameter of the renal artery evaluated by renal artery CTA is ≥3 mm and the length is ≥20 mm; The patient or his/her legal representative signs a written informed consent form approved by the ethics committee before screening;

Exclusion Criteria

Complicated with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined as plasma Hb1Ac ≥ 10.0%); Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²; Previous implantation of an implantable cardioverter-defibrillator (ICD) or a pacemaker; History of myocardial infarction, syncope, intracerebral hemorrhage or cerebral infarction within 6 months before signing the informed consent form; Severe valvular heart stenosis; Any factors that may interfere with blood pressure measurement under any circumstances (for example, the patient has severe peripheral vascular disease, abdominal aortic aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia, severe anemia); Patients with sleep apnea syndrome; Females who are pregnant or breastfeeding, or those who have a plan to conceive within the next year; Other serious organic diseases with an expected lifespan of less than 12 months; Participation in other clinical trials before screening and not yet completed;

a. Visual inspection shows that the diameter stenosis of the renal artery on either side > 50% or there is a renal artery aneurysm on either side; b. Previous history of renal artery interventional treatment; Other situations that the investigator deems unsuitable for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Pulsecare Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingfeng J wang, Postdoctoral fellow

Role: CONTACT

wangjingfeng2017@163.com

02081332199

Facility Contacts

Wang Jing Feng, professor

Role: primary

0086-020-81332199

Other Identifiers

MW-2301-T-01

Identifier Type: -

Identifier Source: org_study_id