[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511097":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventions",null,"Device: Aveir DR Leadless Pacemaker System\n\nThis study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention will be conducted in this study.",[13],"Device: Aveir DR Leadless Pacemaker System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Aveir DR Leadless Pacemaker System","This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention will be conducted in this study.",[9],[21],{"name":22,"affiliation":23,"role":24},"Nicole Harbert","Abbott","STUDY_DIRECTOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","972-526-4841","nicole.harbert@abbott.com",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Stephanie Delgado","818-493-3285","Stephanie.delgado1@abbott.com",[35],{"facility":23,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Sylmar","California","91342","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-118.44925,34.30778,{"lat":46,"lon":45},[49],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":50},"Nicole.Harbert@abbott.com",{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100511097","aveir-dr-real-world-evidence-post-approval-study-100511097",false,"NCT05935007","Aveir DR Real-World Evidence Post-Approval Study","Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study","Eligibility Criteria:\n\n* Implanted with an Aveir DR leadless pacemaker\n* Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period\n* Ability to link with Medicare fee-for-service data","ALL","18 Years",{"count":63,"type":64},1805,"ESTIMATED","OBSERVATIONAL","The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.",[68,69,70],"Cardiac Pacemaker","Arrythmia","Bradycardia",[72,73,74,75,76],"bradycardia","sick sinus rhythm","pacemaker","av block","vasovagal syncope","2026-05-18",{"date":79,"type":80},"2026-05-20","ACTUAL",{"date":82,"type":80},"2023-10-31",{"date":84,"type":64},"2030-12-31",{"name":5,"class":6},1]