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NCT Number: NCT06877234

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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Wang Jing Feng, professor

CONTACT

0086-020-81332199

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Preoperative exclusion criteria based on CTA imaging:

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.

Treatment and study plan

Ultrasonic Nerve Ablation System

Procedure

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

Primary outcomes

  1. The change in the average daytime systolic blood pressure two months after the operation

    Time frame: Two months after the operation

    That is, the difference between the average daytime (from 7:00 to 22:00) systolic blood pressure measured before the operation and the average daytime systolic blood pressure measured during the follow-up visit two months after the operation

  2. Major adverse events within 30 days after the operation

    Time frame: Within 30 days after the operation

    Major adverse events include: all-cause mortality, renal complications, renal artery embolism events, complications of interventional treatment, hypertensive/hypotensive crises during hospitalization, and major cardiovascular and cerebrovascular complications.

Secondary outcomes

  1. The changes in the average systolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation

    Time frame: 1 month, 3 months, 6 months after the operation

    Changes in the average systolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation (1 month, 3 months, 6 months) That is, the difference between the average systolic blood pressure of ambulatory blood pressure measured during the daytime (7:00-22:00), at night (22:00-7:00) and over 24 hours before the operation and the average systolic blood pressure of ambulatory blood pressure measured during the daytime, at night and over 24 hours during the postoperative follow-up.

  2. Changes in the average diastolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation

    Time frame: 1 month, 2 months, 3 months, 6 months after the operation

    That is, the difference between the average diastolic blood pressure of ambulatory blood pressure measured during the daytime (7:00-22:00), at night (22:00-7:00) and over 24 hours before the operation, and the average diastolic blood pressure of ambulatory blood pressure measured during the daytime, at night and over 24 hours during the postoperative follow-up

  3. The attainment rate of systolic blood pressure reaching the standard in the outpatient clinic after the operation

    Time frame: 1 month, 2 months, 3 months, 6 months after the operation

    That is, the proportion of subjects whose systolic blood pressure measured in the outpatient clinic during the postoperative follow-up is less than 140 mmHg.

  4. The change in systolic blood pressure measured in the outpatient clinic after the operation

    Time frame: 1 month, 2 months, 3 months, 6 months after the operation

    That is, the difference between the systolic blood pressure measured in the outpatient clinic before the operation and the systolic blood pressure measured in the outpatient clinic during the postoperative follow-up

  5. The average number of types of medications taken after the operation

    Time frame: 1 month, 2 months, 3 months, 6 months after the operation

    The change in the average number of types of medications taken during the postoperative follow-up period, compared with the antihypertensive medications taken before the operation.

  6. The incidence rate of complications of interventional treatment

    Time frame: 1 month, 2 months, 3 months, 6 months after the operation

    It refers to the intraoperative or postoperative related complications that occur after the research device has completed the renal artery ultrasound ablation surgery, such as renal artery perforation, renal artery dissection, acute infection, etc

  7. All-cause mortality rate

    Time frame: 1 month, 2 months, 3 months, 6 months after the operation

    Death caused by any reason as informed during the clinical follow-up

  8. Cardiovascular and cerebrovascular complications

    Time frame: 1 month, 2 months, 3 months, 6 months after the operation

    It refers to myocardial infarction, any stroke event (including intracerebral hemorrhage and cerebral infarction), and any coronary revascularization

  9. Renal complications

    Time frame: 1 month, 2 months, 3 months, 6 months after the operation

    Refers to eGFR <15 mL/min/1.73㎡, requirement for renal replacement therapy, or renal artery revascularization; renal artery stenosis (refers to diameter stenosis ≥50%).

  10. The incidence rate of adverse events and serious adverse events

    Time frame: 1 month, 2 months, 3 months, 6 months after the operation

    The number of adverse events and serious adverse events

  11. The incidence rate of device defects.

    Time frame: during the operation

    The number of occurrences of device defects

Study contacts

Contact information is provided by the study sponsor or research team.

Jingfeng J wang, Postdoctoral fellow

CONTACT

[email protected]

02081332199

Sponsors and collaborators

Lead sponsor

Shenzhen Pulsecare Medical Technology Co., Ltd.

Industry

Registry information

Official study title

An Exploratory Clinical Study on the Safety and Efficacy of the Ultrasonic Nerve Ablation System in the Treatment of Essential Hypertension

Acronym: ModulationHTN1

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 14, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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