[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610759":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":11,"studyPopulation":21,"armGroups":22,"interventions":31,"overallOfficials":39,"centralContacts":47,"locations":56,"responsibleParty":73,"collaborators":11,"id":75,"slug":11,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":11,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":11,"briefSummary":87,"conditions":88,"keywords":11,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"ReCor Medical, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Assessment for Changes in Blood Pressure",null,"November 2025 - December 2029",[14,16],{"measure":15,"description":11,"timeFrame":12},"Occurrence of Adverse Cardiovascular and Cerebrovascular Event",{"measure":17,"description":11,"timeFrame":12},"Changes in Anti-Hypertensive Medication",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":19,"timePerspective":20,"maskingInfo":11},"COHORT","PROSPECTIVE","Adults aged ≥ 65 years with uncontrolled hypertension",[23,28],{"label":24,"type":11,"description":25,"interventionNames":26},"Exposure Group (uRDN + SOC)","A procedure or device code for the Paradise™ ultrasound renal denervation system (uRDN) and medication records indicating receipt of blood pressure-lowering medications.",[27],"Device: Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)",{"label":29,"type":11,"description":30,"interventionNames":11},"Comparator Group (SOC)","Medication records indicating receipt of blood pressure-lowering medications.",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DEVICE","Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)","A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.",[24],[38],"Paradise™ ultrasound renal denervation system",[40,44],{"name":41,"affiliation":42,"role":43},"Megan Coylewright, MD","Essentia Health","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":43},"Amir Kaki, MD","Ascension St. John Hospital",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":11,"email":52},"Helen Reeve-Stoffer, Ph.D","CONTACT","650-542-7700","hreeve-stoffer@recormedical.com",{"name":54,"role":50,"phone":51,"phoneExt":11,"email":55},"Elizabeth A Sheehan, MLIS, MA","liz.sheehan@recormedical.com",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Henry Ford St. John Hospital","RECRUITING","Detroit","Michigan","48236","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-83.04575,42.33143,{"lat":69,"lon":68},[72],{"name":45,"role":50,"phone":11,"phoneExt":11,"email":11},{"type":74,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610759",false,"NCT07231757","The RADIANCE CED Study","The Recor Paradise System™ Hypertension Coverage With Evidence Development Study","Common Inclusion Criteria:\n\n* Adults aged ≥65 years with uncontrolled hypertension\n* Stable regimen of blood pressure-lowering medication\n\nCommon Exclusion Criteria:\n\n* Hypertension due to secondary causes\n* Prior renal denervation treatment\n* Pregnancy\n* End-stage renal disease, dialysis, or kidney transplant","ALL","65 Years",{"count":84,"type":85},1000,"ESTIMATED","OBSERVATIONAL","The RADIANCE CED study is a prospective observational study designed to evaluate the long-term effectiveness of ultrasound renal denervation in lowering blood pressure among patients with uncontrolled hypertension. Data will be collected from electronic health records (EHRs) of Medicare-eligible patients to support generalizability of outcomes to the broader Medicare population. Individual hospital enrollment is not required for this study and IRB exemption has been received by sponsor.",[89,90,91],"Hypertension","Cardiovascular Diseases","Vascular Diseases","2026-01-07",{"date":94,"type":95},"2026-01-09","ACTUAL",{"date":97,"type":95},"2025-11-21",{"date":99,"type":85},"2031-12-31",{"name":5,"class":6},1]