NCT06877221Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 10 Mar 2025
- Start date
- 25 Jan 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Shenzhen Pulsecare Medical Technology Co., Ltd.
- Diseases
- High blood pressure
- NCT number
- NCT06877221
What you commit to
- Study type: Interventional
- Planned participants: 204
- From 25 Jan 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- CTA, MRA, or DSA examination shows that the shape and structure of the unilateral or bilateral renal arteries are not suitable for ablation surgery (renal artery stenosis exceeding 50%, renal artery aneurysm, fibromuscular dysplasia of the renal artery, or the diameter of the main renal artery is less than 3 mm).
- Having only one kidney or having received a kidney transplant.
- Having a history of surgery or trauma requiring hospitalization within 30 days before randomization for enrollment.
- Having a cardiovascular event (stable or unstable angina, myocardial infarction) or cerebrovascular event (stroke, cerebrovascular accident, transient ischemic attack) within 6 months before randomization for enrollment.
- Currently participating in other clinical trials of drugs or medical devices.
Other illness
- Having a history of renal artery interventional treatment or renal denervation surgery.
- Suffering from any condition that may affect the accuracy of blood pressure measurement, such as the upper arm diameter being too large relative to the cuff.
- Secondary hypertension (excluding apnea syndrome).
- Having a history of hospitalization due to hypertensive crisis within one year before randomization for enrollment.
- Suffering from type 1 diabetes.
- Suffering from primary pulmonary hypertension.
- Being allergic to contrast agents.
- Severe cardiac valve stenosis.
- Cardiac insufficiency (NYHA class III - IV).
- Acute or severe systemic infection.
- Having obvious symptoms of active peptic ulcer (such as abdominal pain, nausea, vomiting, regurgitation, etc.).
- Having obvious bleeding tendency and hematological diseases.
Lab values
- Glomerular filtration rate (eGFR) \< 45 mL/min/1.73m² (MDRD formula).
Other
- Hyperthyroidism or hypothyroidism.
- Requiring mechanical ventilation for assisted breathing (except for nocturnal respiratory support for treating sleep apnea).
- Having an implantable cardioverter - defibrillator (ICD) or pacemaker.
- Pregnant, lactating women, or women planning to become pregnant during the study period.
- Other reasons that the investigator deems inappropriate for participation in this study
Who the study is looking for
- Age between 18 and 70 years old (calculated based on the date of starting standardized medication).
- After treatment with at least two types of antihypertensive drugs for 4 weeks or more, the clinic systolic blood pressure is ≥140 mmHg and ≤180 mmHg, and the average 24 - hour ambulatory systolic blood pressure is ≥130 mmHg (or the daytime ambulatory systolic blood pressure is ≥135 mmHg).
- Resting heart rate ≥70 beats per minute without taking beta - blockers (this criterion does not apply to patients taking beta - blockers).
- The subject agrees to participate in this clinical trial, complies with the follow - up required by the trial protocol, and has voluntarily signed the informed consent form
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.