[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510912":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":55,"collaborators":10,"id":57,"slug":10,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aveir DR Leadless Pacemaker System",null,"This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention is required in this study.",[13],"Device: Aveir DR Leadless Pacemaker System",{"label":15,"type":10,"description":16,"interventionNames":17},"Dual Chamber Transvenous Pacemaker","This study will utilize real-world data from patients implanted with a dual-chamber transvenous pacemaker as a comparator to the Aveir DR LP system study arm. No device intervention is required in this study.",[18],"Device: Dual Chamber Transvenous Pacemaker",[20,23],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":10},"DEVICE",[9],{"type":21,"name":15,"description":16,"armGroupLabels":24,"otherNames":10},[15],[26],{"name":27,"affiliation":28,"role":29},"Nicole Harbert","Abbott","STUDY_DIRECTOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":10,"email":34},"CONTACT","972-526-4841","nicole.harbert@abbott.com",{"name":36,"role":32,"phone":37,"phoneExt":10,"email":38},"Stephanie Delgado","818-493-3285","stephanie.delgado1@abbott.com",[40],{"facility":28,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Sylmar","California","91342","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-118.44925,34.30778,{"lat":51,"lon":50},[54],{"name":27,"role":32,"phone":33,"phoneExt":10,"email":34},{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100510912",false,"NCT05932602","AVEIR DR Coverage With Evidence Development (CED) Study","The AVEIR DR Coverage With Evidence Development (DRIVE) Study","Inclusion Criteria:\n\n* Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.\n\nOR\n\nMedicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date\n\nExclusion Criteria:\n\nNone","ALL","18 Years",{"count":66,"type":67},2812,"ESTIMATED","OBSERVATIONAL","The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).",[71,72,73],"Cardiac Pacemaker","Arrythmia","Bradycardia",[75,76,77,78],"dual chamber","sick sinus rhythm","pacemaker","AV Block","2025-04-03",{"date":81,"type":82},"2025-04-06","ACTUAL",{"date":84,"type":82},"2023-10-31",{"date":86,"type":67},"2030-05",{"name":5,"class":6},1]