[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"icd-malfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:icd-malfunction":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":20,"type":21},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.",[26,27,28,29,30],"Cardiac Pacemaker Malfunction","ICD Malfunction","Cardiac Pacemaker Electrical Interference","Anesthesia Complication","Surgery--Complications",[32,33,34,35],"pacemaker","implanted cardioverter defibrillator","cardiac resynchronisation therapy","management, peri-operative","RECRUITING","2024-10-11",{"date":39,"type":40},"2024-10-15","ACTUAL",{"date":42,"type":40},"2018-11-27",{"date":44,"type":21},"2030-12-31",{"name":46,"class":47},"Klinikum-Fuerth","OTHER",2]