Actively Recruiting
Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN（FIM）
Led by Shenzhen Pulsecare Medical Technology Co., Ltd. · Updated on 2025-06-19
6
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN（FIM）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Blood pressure meets the following: outpatient systolic 150-180 mmHg and diastolic 60 mmHg; 24-hour ambulatory systolic 135-170 mmHg
- Hypertension duration of more than 6 months
- Renal artery diameter 60 mm and length 6520 mm as evaluated by renal artery CTA
- Patient or legal representative signs informed consent form approved by ethics committee
You will not qualify if you...
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (plasma Hb1Ac 6510.0%)
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m8
- Previous implantation of implantable cardioverter-defibrillator (ICD) or pacemaker
- History of myocardial infarction, syncope, intracerebral hemorrhage, or cerebral infarction within 6 months before consent
- Severe valvular heart stenosis
- Conditions interfering with blood pressure measurement, such as severe peripheral vascular disease, abdominal aortic aneurysm, hemorrhagic disorders, or severe anemia
- Sleep apnea syndrome
- Females who are pregnant, breastfeeding, or plan to conceive within the next year
- Other serious organic diseases with expected lifespan less than 12 months
- Participation in other clinical trials before screening and not yet completed
- Renal artery diameter stenosis greater than 50% or renal artery aneurysm on either side
- Previous renal artery interventional treatment
- Other investigator-deemed unsuitable situations for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
J
Jingfeng J wang, Postdoctoral fellow
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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