[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601310":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":47,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":79,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Henan Institute of Cardiovascular Epidemiology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Laparoscopic Adventitial RDN","EXPERIMENTAL","Participants will undergo a 28-day run-in period on a standardized antihypertensive medication regimen. Following this period, all participants will receive the investigational treatment, which is a laparoscopic renal artery adventitial denervation procedure. Participants will be followed for 180 days post-procedure",[13],"Device: Renal Artery Radiofrequency Ablation Clamp",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Chuanyu Gao, MD, Phd","CONTACT","13937165590","gaocy6208@163.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Fuwai Huazhong Cardiovascular Hospital","Zhengzhou","Henan","China","CN",{"type":35,"coordinates":36},"Point",[37,38],113.64861,34.75778,{"lat":38,"lon":37},[41],{"name":42,"role":24,"phone":25,"phoneExt":20,"email":26},"Chuanyu Gao, MD，Phd",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Chuanyu Gao","Professor",[48,51],{"name":49,"class":50},"Hunan Ept Medical Co., Ltd.","UNKNOWN",{"name":52,"class":50},"Shanghai Hongtong Industrial Co., Ltd.","100601310","laparoscopic-adventitial-renal-denervation-rdn-for-refractory-hypertension-100601310",false,"NCT07108829","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","Inclusion Criteria:\n\nAge ≥18 years and ≤65 years, any sex.\n\nDiagnosed with primary hypertension.\n\nHistory of hypertension for at least 6 months.\n\nBlood pressure meets the following two conditions:\n\nOffice systolic blood pressure ≥140mmHg and ≤180mmHg, and office diastolic blood pressure ≥90mmHg. If not taking a beta-blocker, resting heart rate must be ≥70bpm.\n\n24-hour ambulatory blood pressure measurement shows an average systolic pressure ≥130mmHg or a daytime average systolic pressure ≥135mmHg.\n\nHas 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.\n\nPatient is willing and able to comply with follow-up requirements and has signed the informed consent form.\n\nExclusion Criteria:\n\nSecondary hypertension.\n\nTarget renal artery anatomy is unsuitable, including:\n\nRenal artery diameter \\>9mm or \\\u003C4mm.\n\nMultiple renal arteries.\n\nSevere calcification, stenosis \\>50%, malformation, fibromuscular dysplasia, or aneurysm in either renal artery.\n\nHistory of renal artery intervention (e.g., balloon angioplasty or stenting).\n\nUnsuitable for laparoscopic surgery via the retroperitoneal approach, including prior retroperitoneal surgery, retroperitoneal fibrosis, or severe obesity (BMI \\> 40 kg\u002Fm²).\n\nHistory of kidney transplant or severe renal impairment (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73m²).\n\nHospitalization for a hypertensive crisis within the past year.\n\nSevere liver dysfunction (ALT or AST \\> 3 times the upper limit of normal).\n\nType 1 diabetes.\n\nHistory of a cardiovascular event (e.g., myocardial infarction, unstable angina) or cerebrovascular event (e.g., stroke, TIA) within the last 6 months.\n\nPregnancy or planning to become pregnant during the trial.\n\nParticipation in any other investigational drug or device trial within 3 months prior to screening.","ALL","18 Years","65 Years",{"count":64,"type":65},10,"ESTIMATED","INTERVENTIONAL",[68],"NA","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.\n\nThe 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.\n\nThe 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.\n\nParticipants 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.",[71],"Refractory Hypertension or Drug-intolerant Hypertension",[73,74,75,76,77,78],"Hypertension","Resistant Hypertension","Renal Denervation","Laparoscopic","Radiofrequency Ablation","Sympathetic Nerves","NOT_YET_RECRUITING","2025-07-31",{"date":82,"type":83},"2025-08-07","ACTUAL",{"date":85,"type":65},"2025-08",{"date":87,"type":65},"2026-08",{"name":5,"class":6},1]