Tests a new device treatment for hard-to-control high blood pressure
Tests a new keyhole kidney-artery heat device in adults with resistant high blood pressure.
Plain-language title generated from the registry record
Registry title: Laparoscopic Adventitial Renal Denervation (RDN) for Refractory Hypertension
Key facts
- Where
- Zhengzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07108829, who can take part
Where in China
- Fuwai Huazhong Cardiovascular HospitalZhengzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Henan Institute of Cardiovascular Epidemiology
- Trial code
- NCT07108829
- Record updated
- 7 August 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; 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; 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); 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.