[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SyMap Medical (Suzhou), Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100618808","smart-ic-pilot-study-100618808",false,"NCT07336433","SMART-IC-Pilot Study","EFS Study of the Renal Nerve Mapping\u002FSelective Renal Denervation (msRDN) System in the Absence of Antihypertensive Medications: A Prospective, Multicentre, Single-Arm Exploratory Trial","SMART-IC-Pilot","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Documented essential hypertension\n3. Resistant or drug-intolerant hypertension, particularly in patients requiring medication reduction\n4. Office BP ≥ 140\u002F90 mmHg and \\\u003C 180\u002F110 mmHg while on a stable regimen of 1-2 antihypertensive medications for ≥ 4 weeks before consent\n5. Documented daytime ASBP ≥ 135 mmHg and \\\u003C 170 mmHg after 2-week washout\n6. Able and willing to comply with all study procedures and follow-up visit\n\nExclusion Criteria:\n\n1.Renal artery anatomy on either side, unsuitable for treatment:\n\n1. Main renal artery diameter \\\u003C 4 mm or \\> 8 mm\n2. Main renal artery length \\\u003C 25 mm\n3. Single functioning kidney\n4. Presence of abnormal kidney (or secreting adrenal) tumors\n5. Renal artery with aneurysm\n6. Pre-existing renal stent or history of renal artery angioplasty\n7. Prior renal denervation procedure\n8. Renal artery stenosis ≥ 50% 2.Active infection within 7 days of procedure 3.Iliac\u002Ffemoral artery stenosis precluding msRDN catheter insertion 4.Type I diabetes mellitus 5.eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2 (by Modification of Diet in Renal Disease formula) 6.Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) 7.Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) 8.Documented confirmed episode(s) of stable or unstable angina 9.Documented repeat (\\> 1) hospitalization for hypertensive crisis within the prior 12 months 10.Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea 11.Primary pulmonary hypertension 12.Documented contraindication or allergy to contrast medium not amenable to treatment 13.Limited life expectancy of \\\u003C 1 year at the discretion of the Investigator 14.Known drug\u002Falcohol dependence or inability to comply with study protocol Pregnant, breastfeeding or intend to become pregnant within 12 months -","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","This small-scale, proof-of-concept pilot study aims to obtain preliminary evidence of msRDN procedural safety, feasibility, and short-term efficacy in patients with hypertension without medication therapy, to adequately plan an appropriate pivotal study.",[27],"Hypertensive Disease","NOT_YET_RECRUITING","2026-01-12",{"date":31,"type":32},"2026-01-13","ACTUAL",{"date":34,"type":21},"2026-01-01",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"SyMap Medical (Suzhou), Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":40},"100576085","smart-study-in-real-world-100576085","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.",{"count":50,"type":21},1000,"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.",[54,55,56,57],"Hypertension","Uncontrolled Hypertension","Resistant Hypertension","Reduce Antihypertensive Drug Burden",[59,60,61,62],"uncontrolled hypertension","hypertension","reduce antihypertensive medications","resistant hypertension","2025-02-13",{"date":65,"type":32},"2025-02-17",{"date":67,"type":21},"2025-02",{"date":69,"type":21},"2029-04",{"name":38,"class":39},""]