[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482355":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":24,"responsibleParty":41,"collaborators":7,"id":43,"slug":7,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":7,"enrollmentInfo":51,"targetDuration":54,"studyType":55,"phases":7,"briefSummary":56,"conditions":57,"keywords":7,"overallStatus":27,"whyStopped":7,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Biotronik SE & Co. KG","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)","Ablations and diagnostic catheters are indicated for temporary transvenous application in patients with cardiac arrhythmias during electrophysiology study (EPS) or catheter ablation interventions. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and \u002F or irrigation pumps.",[14,20],{"name":15,"role":16,"phone":17,"phoneExt":18,"email":19},"Ines Danzke","CONTACT","+49 (0) 151 6890","1352","ines.danzke@biotronik.com",{"name":21,"role":16,"phone":17,"phoneExt":22,"email":23},"Annette Thiem, Dr.","1303","annette.thiem@biotronik.com",[25],{"facility":26,"status":27,"city":28,"state":7,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Städtisches Krankenhaus Friedrichshafen","RECRUITING","Friedrichshafen","88048","Germany","DE",{"type":33,"coordinates":34},"Point",[35,36],9.47554,47.65689,{"lat":36,"lon":35},[39],{"name":40,"role":16,"phone":7,"phoneExt":7,"email":7},"Hansjörg Bauerle, Dr. med.",{"type":42,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100482355",false,"NCT05560958","Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products","BIO|COLLECT-EP","Inclusion Criteria:\n\n* Indication for diagnostic or therapeutic EP intervention\n* EP intervention is planned to involve the use of BIOTRONIK EP products from at least 2 of the 3 following categories:\n\n  * BIOTRONIK catheter (AlCath, ViaCath, MultiCath, Khelix)\n  * BIOTRONIK external device (Qubic Stim, Qubic RF, Qiona)\n  * BIOTRONIK transseptal sheath (Senovo Bi-Flex)\n* BIOTRONIK EP product is planned to be used within its intended purpose\n* Ability to understand the nature of the study\n* Willingness to provide written informed consent\n* Ability and willingness to perform all follow-up visits at the study site\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Pregnant or breastfeeding\n* Prior participation in this study with performed EP procedure\n* Participation in an interventional clinical investigation in parallel to the BIO\\|COLLECT.EP study","ALL","18 Years",{"count":52,"type":53},280,"ESTIMATED","6 Months","OBSERVATIONAL","This data collection is designed to provide evidence for the safety, performance, and clinical benefit of BIOTRONIK's EP products. Additionally, residual risks will be monitored and newly emerging risks identified.",[58],"Cardiac Arrhythmia","2025-09-16",{"date":61,"type":62},"2025-09-17","ACTUAL",{"date":64,"type":62},"2023-01-16",{"date":66,"type":53},"2030-07",{"name":5,"class":6},1]