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NCT07108829

Laparoscopic Adventitial Renal Denervation (RDN) for Refractory Hypertension

Sponsor: Henan Institute of Cardiovascular Epidemiology

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08

Completion Date

2026-08

Last Updated

2025-08-07

Healthy Volunteers

Conditions

Refractory Hypertension or Drug-intolerant Hypertension

Interventions

DEVICE

Renal Artery Radiofrequency Ablation Clamp

This device is a clamp used during a laparoscopic surgical procedure. It is placed on the external surface (adventitia) of the renal artery and is connected to a radiofrequency generator. It delivers targeted radiofrequency energy to ablate the renal sympathetic nerves.

Inclusion Criteria: 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 Criteria: Secondary hypertension. 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. History of renal artery intervention (e.g., balloon angioplasty or stenting). Unsuitable for laparoscopic surgery via the retroperitoneal approach, including prior retroperitoneal surgery, retroperitoneal fibrosis, or severe obesity (BMI \> 40 kg/m²). History of kidney transplant or severe renal impairment (eGFR \< 45 mL/min/1.73m²). Hospitalization for a hypertensive crisis within the past year. Severe liver dysfunction (ALT or AST \> 3 times the upper limit of normal). 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. Pregnancy or planning to become pregnant during the trial. Participation in any other investigational drug or device trial within 3 months prior to screening.

Locations (1)

Fuwai Huazhong Cardiovascular Hospital

Zhengzhou, Henan, China