[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523827":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":57,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aveir AR Leadless Pacemaker",null,"This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.",[13],"Device: Aveir AR Leadless Pacemaker",{"label":15,"type":10,"description":16,"interventionNames":17},"Single-Chamber Atrial Transvenous Pacemaker","This study will utilize real-world data from patients implanted with a single-chamber atrial transvenous pacemaker as a comparator to the Aveir AR LP study arm. No device intervention is required in this study.",[18],"Device: Single-chamber atrial transvenous pacemaker",[20,23],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":10},"DEVICE",[9],{"type":21,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Single-chamber atrial transvenous pacemaker","This study will utilize real-world data from patients implanted with a single-chamber atrial transvenous pacemaker as a comparator to the Aveir AR LP study arm. No device intervention is required in this study",[15],[28],{"name":29,"affiliation":30,"role":31},"Nicole Harbert","Abbott","STUDY_DIRECTOR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":10,"email":36},"CONTACT","972-526-4841","nicole.harbert@abbott.com",{"name":38,"role":34,"phone":39,"phoneExt":10,"email":40},"Stephanie Delgado","818-493-3285","stephanie.delgado1@abbott.com",[42],{"facility":30,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Sylmar","California","91342","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-118.44925,34.30778,{"lat":53,"lon":52},[56],{"name":29,"role":34,"phone":35,"phoneExt":10,"email":10},{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100523827","aveir-ar-coverage-with-evidence-development-ced-study-100523827",false,"NCT06100770","Aveir AR Coverage With Evidence Development (CED) Study","ARRIVE","Inclusion Criteria:\n\n1. Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date (i.e., the date of Aveir AR market approval) will be included in the study.\n\n   OR\n2. Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial transvenous pacemaker on or after the study start date\n\nExclusion Criteria:\n\n* None","ALL","18 Years",{"count":69,"type":70},586,"ESTIMATED","OBSERVATIONAL","The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).",[74,75,76],"Cardiac Pacemaker","Arrhythmia","Bradycardia","2025-04-02",{"date":79,"type":80},"2025-04-04","ACTUAL",{"date":82,"type":80},"2024-01-18",{"date":84,"type":70},"2031-01",{"name":5,"class":6},1]