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.
None
None
Single group
Ultrasonic Nerve Ablation System
Procedure/SurgeryTreatment of patients with essential hypertension using the ultrasonic nerve ablation system
The change in the average daytime systolic blood pressure 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
Major adverse events 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.
The changes in the average systolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours 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.
Changes in the average diastolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours 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
The attainment rate of systolic blood pressure reaching the standard in the outpatient clinic 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.
The change in systolic blood pressure measured in the outpatient clinic 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
Click on the lead sponsor to view all of their trials.
