[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511097":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":50,"collaborators":10,"id":52,"slug":10,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"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,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Sylmar","California","91342","United States",{"type":42,"coordinates":43},"Point",[44,45],-118.44925,34.30778,{"lat":45,"lon":44},[48],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":49},"Nicole.Harbert@abbott.com",{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":61,"type":62},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.",[66,67,68],"Cardiac Pacemaker","Arrythmia","Bradycardia",[70,71,72,73,74],"bradycardia","sick sinus rhythm","pacemaker","av block","vasovagal syncope","2026-05-18",{"date":77,"type":78},"2026-05-20","ACTUAL",{"date":80,"type":78},"2023-10-31",{"date":82,"type":62},"2030-12-31",{"name":5,"class":6},1]