NCT07108829Not yet recruiting
Laparoscopic Adventitial Renal Denervation (RDN) for Refractory Hypertension
First-in-Man Clinical Study to Evaluate the Safety and Efficacy of Renal Artery Radiofrequency Ablation Clamp, Radiofrequency Ablation Generator for the Adjunctive Treatment of Refractory Hypertension and Drug-Intolerant Hypertension
Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a first-in-human study to test the safety and effectiveness of a new device-based treatment for high blood pressure that is difficult to control with medicine. This condition is known as refractory hypertension. The study will enroll 10 adults aged 18 to 65 whose high blood pressure is not controlled even though they are taking three or more blood pressure medications. The treatment involves a new medical device called a Renal Artery Radiofrequency Ablation Clamp. This device is used during a keyhole (laparoscopic) surgery. It works by applying controlled heat (radiofrequency energy) to the outside of the arteries that supply blood to the kidneys. This procedure, known as renal denervation, aims to calm the nerves around these arteries that contribute to high blood pressure. Participants who join the study will first be monitored on a standard set of blood pressure medicines to confirm they are eligible. If they qualify, they will undergo the keyhole surgery. After the procedure, participants will be followed for 180 days (about 6 months) and will have several follow-up visits to check their blood pressure and overall health.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 31 Jul 2025
- Start date
- Aug 2025
- Primary completion date
- Aug 2026
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Diseases
- High blood pressure
- NCT number
- NCT07108829
What you commit to
- Study type: Interventional
- Planned participants: 10
- From Aug 2025 to the primary completion date, Aug 2026
- 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
- Unsuitable for laparoscopic surgery via the retroperitoneal approach, including prior retroperitoneal surgery, retroperitoneal fibrosis, or severe obesity (BMI \> 40 kg/m²).
- Participation in any other investigational drug or device trial within 3 months prior to screening.
Other illness
- Secondary hypertension.
- History of renal artery intervention (e.g., balloon angioplasty or stenting).
- Type 1 diabetes.
- History of a cardiovascular event (e.g., myocardial infarction, unstable angina) or cerebrovascular event (e.g., stroke, TIA) within the last 6 months.
Lab values
- History of kidney transplant or severe renal impairment (eGFR \< 45 mL/min/1.73m²).
- Severe liver dysfunction (ALT or AST \> 3 times the upper limit of normal).
Other
- Target renal artery anatomy is unsuitable, including:
- Renal artery diameter \>9mm or \<4mm.
- Multiple renal arteries.
- Severe calcification, stenosis \>50%, malformation, fibromuscular dysplasia, or aneurysm in either renal artery.
- Hospitalization for a hypertensive crisis within the past year.
- Pregnancy or planning to become pregnant during the trial.
Who the study is looking for
- Age ≥18 years and ≤65 years, any sex.
- Diagnosed with primary hypertension.
- History of hypertension for at least 6 months.
- Blood pressure meets the following two conditions:
- Office systolic blood pressure ≥140mmHg and ≤180mmHg, and office diastolic blood pressure ≥90mmHg. If not taking a beta-blocker, resting heart rate must be ≥70bpm.
- 24-hour ambulatory blood pressure measurement shows an average systolic pressure ≥130mmHg or a daytime average systolic pressure ≥135mmHg.
- Has a history of antihypertensive medication use within the last 6 months with uncontrolled blood pressure. Before enrollment, must undergo at least 28 days of a standardized medication regimen (including a diuretic and at least three drugs in total) with ≥80% compliance, while office SBP remains ≥140mmHg and ≤180mmHg, and office DBP remains ≥90mmHg.
- Patient is willing and able to comply with follow-up requirements and has signed the informed consent form.
Age in the registry: 18 years to 65 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 |
|---|---|---|---|
| Fuwai Huazhong Cardiovascular Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.