[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100389035":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":21,"interventions":21,"overallOfficials":27,"centralContacts":31,"locations":39,"responsibleParty":57,"collaborators":21,"id":60,"slug":21,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":21,"maxAge":21,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":21,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":42,"whyStopped":21,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"National Cerebral and Cardiovascular Center, Japan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of procedural success","Procedural success was defined as complete or partial and is identified for each lead extracted.","Through discharge from hospital, approximately up to 2 weeks.",[14,17],{"measure":15,"description":16,"timeFrame":12},"Number of in-hospital deaths","All-cause death, cardiovascular death, and procedure-related death",{"measure":18,"description":19,"timeFrame":20},"Number of patients with procedure-related complications","Bleeding events, embolic events, other all complications. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria.","4 weeks",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"CASE_CONTROL","PROSPECTIVE","Japanese Lead Extraction (J-LEX) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, collaborated with National Cerebral and Cardiovascular Center. This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system until 30 days after the lead extraction. The investigators will collect the data regarding patient's background and lead characteristic, medical history, details about lead extraction procedure, lead characteristics, and outcomes. The data were anonymized in a linkable manner at each study site before they were sent. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.","Inpatients",[28],{"name":29,"affiliation":5,"role":30},"Kengo Kusano, MD, PhD","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","+81-6-6170-1070","kusanokengo@ncvc.go.jp",{"name":37,"role":33,"phone":34,"phoneExt":21,"email":38},"Misa Takegami, PhD, MPH","takegami@ncvc.go.jp",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"National Cerebral and Cardiovascular Center","RECRUITING","Suita","Osaka","564-8565","Japan","JP",{"type":49,"coordinates":50},"Point",[51,52],135.51567,34.76143,{"lat":52,"lon":51},[55,56],{"name":29,"role":33,"phone":34,"phoneExt":21,"email":35},{"name":37,"role":33,"phone":34,"phoneExt":21,"email":38},{"type":30,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Kengo Kusano","Director of Cardiovascular Medicine, National Cerebral and Cardiovascular Center","100389035",false,"NCT04345627","Japanese Lead Extraction Registry","J-LEX","Inclusion Criteria:\n\n* Patients undergoing transvenous lead extraction in Japan.\n\nExclusion Criteria:\n\n* Patients who receive open-chest surgical extraction alone.\n* Patients who refused to consent.","ALL",{"count":68,"type":69},5000,"ESTIMATED","30 Days","OBSERVATIONAL","Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The acute success rate at discharge and the complications associated with transvenous lead extraction will be collected. J-LEX registry will provide a reliable information on indications, methods, the success rate, complications and the prognosis at 30 days prognosis.",[74],"Arrhythmia, Cardiac",[76,77,78,79,80],"Lead extraction","Pacemaker","Defibrillator","Complication","REDCap","2023-11-08",{"date":83,"type":84},"2023-11-13","ACTUAL",{"date":86,"type":84},"2018-07-01",{"date":88,"type":69},"2032-03-31",{"name":5,"class":6},1]