[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601153":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":10,"centralContacts":46,"locations":55,"responsibleParty":249,"collaborators":10,"id":251,"slug":252,"hasResults":253,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":10,"eligibilityCriteria":257,"healthyVolunteers":253,"sex":258,"minAge":10,"maxAge":10,"enrollmentInfo":259,"targetDuration":262,"studyType":263,"phases":10,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary Analysis Cohort",null,"This survey targets the registration of 194 patients indicated for de novo dual-chamber LP's. All de novo patients will be followed until the last de novo dual-chamber patient (Aveir Japan PMS primary analysis cohort) reaches 3 years of follow-up",[13],"Device: Aveir DR Leadless Pacemaker Implant",{"label":15,"type":10,"description":16,"interventionNames":17},"Single-chamber atrial Aveir patients","Up to 50 patients indicated for a de novo atrial LP may be registered during the primary de novo dual-chamber LP registration period. Data will be analyzed separately, and the patients will be followed until the last de novo dual-chamber patient (primary analysis cohort) reaches 3 years of follow-up",[18],"Device: Single-chamber atrial Aveir patients",{"label":20,"type":10,"description":21,"interventionNames":22},"Upgrade Patients","Up to 36 upgrade patients (existing ventricular LP to dual-chamber LP system or existing atrial LP to dual-chamber LP system) may be registered during the primary de novo dual-chamber LP registration period. Data will be analyzed separately, and the patients will be followed until the last de novo dual-chamber patient (primary analysis cohort) reaches 3 years of follow-up",[23],"Device: Upgrades",{"label":25,"type":10,"description":26,"interventionNames":27},"Rollover","All patients from Japan sites with existing active Aveir LPs from the Aveir DR IDE i2i Study (up to 24 patients) are eligible to roll over into the Aveir Japan PMS upon consent for ongoing follow-up. Data from the rollover patients will be summarized separately. Rollover patients will be followed until the last de novo dual-chamber patient (Aveir Japan PMS primary analysis cohort) reaches 3 years of follow-up",[28],"Device: Roll-over",[30,35,38,42],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"DEVICE","Aveir DR Leadless Pacemaker Implant","Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium",[9],{"type":31,"name":15,"description":36,"armGroupLabels":37,"otherNames":10},"Patients will undergo a single chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right atrium",[15],{"type":31,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"Upgrades","Patients with an existing single-chamber leadless pacemaker will undergo a leadless pacemaker system implant wherein an additional leadless pacemaker will be implanted in either the right ventricle or right atrium to form a dual-chamber LP system.",[20],{"type":31,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"Roll-over","Patients with an existing active Aveir DR leadless pacemaker system are eligible to be rolled into the Aveir Japan PMS upon consent for ongoing follow-up.",[25],[47,52],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},"Mieko Otake","CONTACT","+81-80-5866-9006","mieko.otake@abbott.com",{"name":53,"role":49,"phone":10,"phoneExt":10,"email":54},"Stephanie Delgado","stephanie.delgado1@abbott.com",[56,75,90,105,119,134,149,161,173,187,202,211,225,238],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Nagoya University Hospital","RECRUITING","Nagoya","Aichi-ken","466-8550","Japan","JP",{"type":65,"coordinates":66},"Point",[67,68],136.90641,35.18147,{"lat":68,"lon":67},[71],{"name":72,"role":49,"phone":73,"phoneExt":10,"email":74},"Yasuya Inden","052-789-5111","inden@med.nagoya-u.ac.jp",{"facility":76,"status":58,"city":77,"state":78,"zip":79,"country":62,"countryCode":63,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Kokura Memorial Hospital","Kitakyushu","Fukuoka","802-8555",{"type":65,"coordinates":81},[82,83],130.85034,33.85181,{"lat":83,"lon":82},[86],{"name":87,"role":49,"phone":88,"phoneExt":10,"email":89},"Kenji Ando, Dr","81935112000","kenji.ando.rkc@gmail.com",{"facility":91,"status":58,"city":92,"state":93,"zip":94,"country":62,"countryCode":63,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"St. Marianna University School of Medicine Hospital","Kawasaki","Kanagwa","2168511",{"type":65,"coordinates":96},[97,98],139.71722,35.52056,{"lat":98,"lon":97},[101],{"name":102,"role":49,"phone":103,"phoneExt":10,"email":104},"Ikutaro Nakajima","(044) 977-8111","ikutaro0817@marianna-u.ac.jp",{"facility":106,"status":58,"city":107,"state":108,"zip":109,"country":62,"countryCode":63,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Sendai Kousei Hospital","Sendai","Miyagi","981-0914",{"type":65,"coordinates":111},[112,113],140.86667,38.26667,{"lat":113,"lon":112},[116],{"name":117,"role":49,"phone":10,"phoneExt":10,"email":118},"Kennosuke Yamashita","kennosuke.atmm3@gmail.com",{"facility":120,"status":58,"city":121,"state":122,"zip":123,"country":62,"countryCode":63,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Kurashiki Central Hospital","Kurashiki","Okayama-ken","710-0052",{"type":65,"coordinates":125},[126,127],133.76667,34.58333,{"lat":127,"lon":126},[130],{"name":131,"role":49,"phone":132,"phoneExt":10,"email":133},"Hiroshi Tasaka","81-86-422-0210","ht10970@kchnet.or.jp",{"facility":135,"status":58,"city":136,"state":137,"zip":138,"country":62,"countryCode":63,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Kansai Medical University Hospital","Hirakata","Osaka","573-1191",{"type":65,"coordinates":140},[141,142],135.64914,34.81352,{"lat":142,"lon":141},[145],{"name":146,"role":49,"phone":147,"phoneExt":10,"email":148},"Yoko Miyasaka","072-804-0101","kmuccr@kmu.ac.jp",{"facility":150,"status":58,"city":137,"state":137,"zip":151,"country":62,"countryCode":63,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Osaka Keisatsu Hospital","543-8922",{"type":65,"coordinates":153},[154,155],135.50107,34.69379,{"lat":155,"lon":154},[158],{"name":159,"role":49,"phone":10,"phoneExt":10,"email":160},"Hitoshi Minamiguchi","hminamiguchi@gmail.com",{"facility":162,"status":58,"city":163,"state":137,"zip":164,"country":62,"countryCode":63,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"National Cerebral & Cardiovascular Center Hospital","Suita","564-8565",{"type":65,"coordinates":166},[167,168],135.51567,34.76143,{"lat":168,"lon":167},[171],{"name":172,"role":49,"phone":10,"phoneExt":10,"email":10},"Kengo Kusano, MD",{"facility":174,"status":58,"city":175,"state":176,"zip":177,"country":62,"countryCode":63,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Juntendo University Shizuoka Hospital","Izunokuni","Shizuok","410-2295",{"type":65,"coordinates":179},[180,181],138.95143,35.03907,{"lat":181,"lon":180},[184],{"name":185,"role":49,"phone":10,"phoneExt":10,"email":186},"Tomoyuki Shiozawa","t-shio@juntendo.ac.jp",{"facility":188,"status":58,"city":189,"state":190,"zip":191,"country":62,"countryCode":63,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Toho University - Omori Medical Center","Ōta-ku","Tokyo","143-8541",{"type":65,"coordinates":193},[194,195],139.71605,35.56126,{"lat":195,"lon":194},[198],{"name":199,"role":49,"phone":200,"phoneExt":10,"email":201},"Masaya Shinohara","03-3762-4151","masaya.shinohara@med.toho-u.ac.jp",{"facility":203,"status":58,"city":204,"state":190,"zip":205,"country":62,"countryCode":63,"cosmosGeoPoint":10,"geoPoint":10,"contacts":206},"Showa Medical University Hospital","Shinagawa-ku","142-8666",[207],{"name":208,"role":49,"phone":209,"phoneExt":10,"email":210},"Taku Asano","03-3784-8000","ctsc.admin@ofc.showa-u.ac.jp",{"facility":212,"status":58,"city":213,"state":10,"zip":214,"country":62,"countryCode":63,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Chiba University Hospital","Chiba","260-8677",{"type":65,"coordinates":216},[217,218],140.11667,35.6,{"lat":218,"lon":217},[221],{"name":222,"role":49,"phone":223,"phoneExt":10,"email":224},"Yusuke Kondo","043-222-7171","trad-project@chiba-u.jp",{"facility":226,"status":58,"city":190,"state":10,"zip":227,"country":62,"countryCode":63,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Tokyo Medical University Hospital","160-0023",{"type":65,"coordinates":229},[230,231],139.69171,35.6895,{"lat":231,"lon":230},[234],{"name":235,"role":49,"phone":236,"phoneExt":10,"email":237},"Kazuhiro Satomi","81333426111","ksatomi@tokyo-med.ac.jp",{"facility":239,"status":58,"city":190,"state":10,"zip":240,"country":62,"countryCode":63,"cosmosGeoPoint":241,"geoPoint":243,"contacts":244},"Tokyo Women's Hospital","162-8666",{"type":65,"coordinates":242},[230,231],{"lat":231,"lon":230},[245],{"name":246,"role":49,"phone":247,"phoneExt":10,"email":248},"Daigo Yagishita","03-3353-8111","yagishita.daigo@twmu.ac.jp",{"type":250,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100601153","aveir-leadless-pacemaker-japan-pms-100601153",false,"NCT07106788","Aveir Leadless Pacemaker Japan PMS","Aveir Leadless Pacemaker Japan Post Marketing Surveillance","Inclusion Criteria:\n\n* Patient is indicated for dual-chamber or single-chamber atrial leadless pacemaker system\n* Patient is a roll-over patient with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study\n* Patient is an upgrade patient with existing single-chamber Aveir leadless pacemaker that requires an upgrade to a dual-chamber Aveir leadless pacemaker system\n\nExclusion Criteria:\n\n* N\u002FA","ALL",{"count":260,"type":261},304,"ESTIMATED","3 Years","OBSERVATIONAL","The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing. Additionally, the PMS will collect data on rollover patients from the Aveir DR i2i IDE, Aveir AR LP in patients indicated for single-chamber pacing in the right atrium, and upgradeability in patients implanted with single-chamber Aveir atrial or ventricular LP that require an upgrade to a dual-chamber Aveir LP.",[266],"Leadless Pacemaker",[268,269],"leadless pacemaker","AVEIR","2026-05-11",{"date":272,"type":273},"2026-05-13","ACTUAL",{"date":275,"type":273},"2025-05-26",{"date":277,"type":261},"2029-11",{"name":5,"class":6},14]