[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576085":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":28,"locations":38,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":85,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"SyMap Medical (Suzhou), Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective Study",null,"In this cohort, the long-term safety and efficacy of the approved msRDN system will be evaluated in patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications.",[13],"Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator\u002FGenerator",{"label":15,"type":10,"description":16,"interventionNames":10},"Retrospective Study","In this cohort, the safety and efficacy of msRDN system will be evaluated in patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications, who have been treated by msRDN procedure.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DEVICE","SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator\u002FGenerator","Radiofrequency ablation of renal arterial sympathetic nerves",[9],[24],{"name":25,"affiliation":26,"role":27},"JianPing LI, MD","Peking University First Hospital","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Jie WANG, MD, PhD","CONTACT","+86-13511604566","jay329329@yahoo.com",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"JingJing ZHANG, BM","+8613914047970","jjzhang@symapmedical.com",[39],{"facility":26,"status":10,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Beijing","Beijing Municipality","100031","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52],{"name":53,"role":31,"phone":10,"phoneExt":10,"email":10},"Wei MA, MD",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57],{"name":58,"class":59},"Beijing Hisicom Tech Dvpt Inc.","UNKNOWN","100576085","smart-study-in-real-world-100576085",false,"NCT06780696","SMART Study in Real World","Sympathetic Mapping and Ablation of Renal Nerves to Treat Uncontrolled Hypertension in Real World","SMART-RW","1. \\*\\*Inclusion Criteria (for A. Prospective Cohort)\\*\\*\n\n   * Patients are ≥18 years old;\n   * Patients with drug-resistant hypertension patients who are intolerant to drug therapy and, in either case, need to reduce medications;\n   * Patients consent to receive msRDN treatment using the commercially available msRDN system by SyMap Medical (Suzhou), Ltd and to fulfill follow-up requirements.\n2. \\*\\*Exclusion Criteria (for A. Prospective Cohort)\\*\\*\n\n   * Subjects are withdrawn from the study due to various reasons;\n   * Investigators, ethics committees or regulatory agencies may halt or terminate the study due to medical perspectives or ethical considerations.\n3. \\*\\*Inclusion Criteria (for B. Retrospective Cohort)\\*\\*\n\n   * Patients are ≥18 years old;\n   * Patients with drug-resistant hypertension patients who are intolerant to drug therapy and, in either case, need to reduce medications;\n   * Patients who have been received msRDN procedure using commercially available msRDN system by SyMap Medical (Suzhou), Ltd;\n4. \\*\\*Exclusion Criteria (for B. Retrospective Cohort) \\*\\*\n\n   * Subjects are withdrawn from the study due to various reasons;\n   * Investigators, ethics committees or regulatory agencies may halt or terminate the study due to medical perspectives or ethical considerations.","ALL","18 Years",{"count":71,"type":72},1000,"ESTIMATED","OBSERVATIONAL","This study is a multicenter, single-arm, open-label and post-market study in a real world patient population with uncontrolled hypertension to document the long-term safety and efficacy of a renal mapping\u002Fselective renal denervation (msRDN) system (SyMap Medical (Suzhou), Ltd, Suzhou, China) and conducted in accordance with the requirements by National Medical Production Administration (NMPA) of China. The msRDN system consists of a disposable renal artery radiofrequency ablation catheter (Registration No: National Medical Device Approval 20243011383), a console with both electronic stimulation and radiofrequency ablation function (Registration No: National Medical Device Approval 20243011384). The study includes prospective cohort and retrospective cohort.\n\nApproximately1,000 patients with uncontrolled hypertension who undergo msRDN procedure will be recruited from over 30 centers in China. Subjects enrolled in the study will be followed for at least three years after msRDN procedure. This study includes patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications per the inclusion criteria defined in the protocol.",[76,77,78,79],"Hypertension","Uncontrolled Hypertension","Resistant Hypertension","Reduce Antihypertensive Drug Burden",[81,82,83,84],"uncontrolled hypertension","hypertension","reduce antihypertensive medications","resistant hypertension","NOT_YET_RECRUITING","2025-02-13",{"date":88,"type":89},"2025-02-17","ACTUAL",{"date":91,"type":72},"2025-02",{"date":93,"type":72},"2029-04",{"name":5,"class":6},1]