[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465144":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":10,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Device: Aveir VR Leadless Pacemaker System",null,"This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.",[9],{"label":14,"type":10,"description":15,"interventionNames":16},"Device: Single-Chamber Transvenous Pacemaker","This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.",[14],[18,22],{"type":19,"name":20,"description":11,"armGroupLabels":21,"otherNames":10},"DEVICE","Aveir VR Leadless Pacemaker System",[9],{"type":19,"name":23,"description":15,"armGroupLabels":24,"otherNames":10},"Single-Chamber Transvenous Pacemaker",[14],[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":10,"phoneExt":10,"email":37},"Stephanie Delgado","stephanie.delgado1@abbott.com",[39],{"facility":28,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Sylmar","California","91342","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-118.44925,34.30778,{"lat":50,"lon":49},[53],{"name":27,"role":32,"phone":33,"phoneExt":10,"email":34},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100465144","aveir-vr-coverage-with-evidence-development-post-approval-study-100465144",false,"NCT05336877","Aveir VR Coverage With Evidence Development Post-Approval Study","Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study","CED","The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location\n\nInclusion Criteria:\n\nMedicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.\n\nOR\n\nMedicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date\n\nExclusion Criteria:\n\nNone","ALL","18 Years",{"count":67,"type":68},8744,"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 Single-Chamber Leadless Pacemaker device (Aveir VR LP).",[72,73,74],"Cardiac Pacemaker","Arrythmia","Bradycardia","2025-07-29",{"date":77,"type":78},"2025-07-31","ACTUAL",{"date":80,"type":78},"2022-06-21",{"date":82,"type":68},"2028-01-01",{"name":5,"class":6},1]