[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-hypertension-or-drug-intolerant-hypertension\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-hypertension-or-drug-intolerant-hypertension":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Refractory Hypertension or Drug-intolerant Hypertension",[29,30,31,32,33,34],"Hypertension","Resistant Hypertension","Renal Denervation","Laparoscopic","Radiofrequency Ablation","Sympathetic Nerves","NOT_YET_RECRUITING","2025-07-31",{"date":38,"type":39},"2025-08-07","ACTUAL",{"date":41,"type":21},"2025-08",{"date":43,"type":21},"2026-08",{"name":45,"class":46},"Henan Institute of Cardiovascular Epidemiology","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":47},"100583507","safety-and-efficacy-of-modulated-ultrasound-renal-denervation-for-htn-100583507","NCT06877221","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","ModulationHTN2","Inclusion Criteria:\n\n1. Age between 18 and 70 years old (calculated based on the date of starting standardized medication).\n2. 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).\n3. Resting heart rate ≥70 beats per minute without taking beta - blockers (this criterion does not apply to patients taking beta - blockers).\n4. 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\n\nExclusion Criteria:\n\n1. 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).\n2. Having only one kidney or having received a kidney transplant.\n3. Having a history of renal artery interventional treatment or renal denervation surgery.\n4. 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.\n5. Secondary hypertension (excluding apnea syndrome).\n6. Glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73m² (MDRD formula).\n7. Having a history of hospitalization due to hypertensive crisis within one year before randomization for enrollment.\n8. Suffering from type 1 diabetes.\n9. Suffering from primary pulmonary hypertension.\n10. Being allergic to contrast agents.\n11. Severe cardiac valve stenosis.\n12. Cardiac insufficiency (NYHA class III - IV).\n13. Hyperthyroidism or hypothyroidism.\n14. Requiring mechanical ventilation for assisted breathing (except for nocturnal respiratory support for treating sleep apnea).\n15. Acute or severe systemic infection.\n16. Having an implantable cardioverter - defibrillator (ICD) or pacemaker.\n17. Having obvious symptoms of active peptic ulcer (such as abdominal pain, nausea, vomiting, regurgitation, etc.).\n18. Having obvious bleeding tendency and hematological diseases.\n19. Having a history of surgery or trauma requiring hospitalization within 30 days before randomization for enrollment.\n20. 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.\n21. Pregnant, lactating women, or women planning to become pregnant during the study period.\n22. Currently participating in other clinical trials of drugs or medical devices.\n23. Other reasons that the investigator deems inappropriate for participation in this study","70 Years",{"count":58,"type":21},204,[24],"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.",[27],"RECRUITING","2025-06-16",{"date":65,"type":39},"2025-06-19",{"date":67,"type":39},"2025-01-25",{"date":69,"type":21},"2030-12",{"name":71,"class":72},"Shenzhen Pulsecare Medical Technology Co., Ltd.","INDUSTRY"]