[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100387938":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":26,"responsibleParty":57,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":7,"enrollmentInfo":72,"targetDuration":75,"studyType":76,"phases":7,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Klinikum-Fuerth","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","surgery or catheter based cardiac procedure (catheter ablation)","patients with implanted CIED (pacemaker, ICD or CRT) that undergo any surgery or any catheter based cardiac procedure (e.g. radiofrequency ablation)",[14],{"name":15,"affiliation":16,"role":17},"Dirk Bastian, MD","Klinikum Fuerth, European Society of Cardiology, European Heart Rhythm Society","PRINCIPAL_INVESTIGATOR",[19,23],{"name":15,"role":20,"phone":21,"phoneExt":7,"email":22},"CONTACT","+49 (0)911 7580 1101","dirk.bastian@klinikum-fuerth.de",{"name":24,"role":20,"phone":21,"phoneExt":7,"email":25},"Laura Vitali-Serdoz, MD","laura.vitali-serdoz@klinikum-fuerth.de",[27,44],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Klinikum Fuerth","RECRUITING","Fürth","Bavaria","90766","Germany","DE",{"type":36,"coordinates":37},"Point",[38,39],10.98856,49.47593,{"lat":39,"lon":38},[42,43],{"name":15,"role":20,"phone":21,"phoneExt":7,"email":22},{"name":24,"role":20,"phone":21,"phoneExt":7,"email":25},{"facility":45,"status":29,"city":46,"state":31,"zip":47,"country":33,"countryCode":34,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Klinikum Nuernberg","Nuremberg","90471",{"type":36,"coordinates":49},[50,51],11.07752,49.45421,{"lat":51,"lon":50},[54],{"name":55,"role":20,"phone":7,"phoneExt":7,"email":56},"Timur Mamedov","timur.mamedov@klinikum-nuernberg.de",{"type":58,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[60],{"name":61,"class":6},"Klinikum Nürnberg","100387938","perioperative-management-evaluation-in-patients-with-cied-100387938",false,"NCT04331249","Perioperative Management Evaluation in Patients With CIED","Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices","EVINCE","Inclusion Criteria:\n\n* implanted CIED (e.g. pacemaker, ICD, CRT),\n* performed (non-CIED related) surgical or catheter-based procedure,\n* data from peri-procedural CIED interrogation available\n* age \\>18 years\n\nExclusion Criteria:\n\n* no implanted CIED,\n* no data from any peri-interventional CIED interrogation available","ALL","18 Years",{"count":73,"type":74},500,"ESTIMATED","1 Month","OBSERVATIONAL","Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.\n\nObjective: To evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter-interventional procedures in clinical routine.\n\nStudy design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics\n\nPrimary endpoint: number and type of peri-operative adverse device related events (ADE) Secondary endpoints: pre-interventional data (patient characteristics, data from CIED interrogation); peri-interventional data (type of surgery\u002Fintervention, anesthesiology techniques, any AE), postinterventional data (data from post-interventional CIED interrogation, need for reprogramming \u002F device revision).\n\nInclusion criteria: implanted CIED, non-CIED related surgical or catheter-based intervention, peri-procedural CIED interrogation, age \\>18 years Exclusion criteria: no implanted CIED, no data from any peri-procedural CIED interrogation available\n\nPatient enrollment: retrospectively beginning from 2008, further on-going prospective inclusion Sample size: For the observational study, there is no pre-specified sample size. Data from more than 500 patients undergoing \\> 700 interventions are expected.",[79,80,81,82,83],"Cardiac Pacemaker Malfunction","ICD Malfunction","Cardiac Pacemaker Electrical Interference","Anesthesia Complication","Surgery--Complications",[85,86,87,88],"pacemaker","implanted cardioverter defibrillator","cardiac resynchronisation therapy","management, peri-operative","2024-10-11",{"date":91,"type":92},"2024-10-15","ACTUAL",{"date":94,"type":92},"2018-11-27",{"date":96,"type":74},"2030-12-31",{"name":5,"class":6},2]