[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575393":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":60,"collaborators":20,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":20,"maxAge":20,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":49,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Universitätsklinikum Köln","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"S-ICD Implantation","EXPERIMENTAL","Patients are implanted with an S-ICD according to standard clinical practice. 1) The ideal lead and device position are determined using the new US method. Any deviation by more than 0.5 cm is counted as a significant deviation. 2) The intraoperative PRAETORIAN Score is calculated based on additional intraoperative measurements.",[13],"Diagnostic Test: Intraoperative PRAETORIAN Score",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Intraoperative PRAETORIAN Score","The intraoperative PRAETORIAN Score is calculated based on the additional measurements.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jakob Luker, MD","CONTACT","+4947832396","jakob.luker@uk-koeln.de",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},"Jonas Worman, MD","jonas.worman@uk-koeln.de",[31,48],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"University Hospital Cologne","NOT_YET_RECRUITING","Cologne","North Rhine-Westphalia","50937","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],6.95,50.93333,{"lat":43,"lon":42},[46],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":47},"jakob.lueker@uk-koeln.de",{"facility":32,"status":49,"city":34,"state":20,"zip":50,"country":37,"countryCode":38,"cosmosGeoPoint":51,"geoPoint":53,"contacts":54},"RECRUITING","50823",{"type":40,"coordinates":52},[42,43],{"lat":43,"lon":42},[55,56,58],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":28,"role":24,"phone":20,"phoneExt":20,"email":57},"jones.worman@uk-koeln.de",{"name":23,"role":59,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100575393","s-icd-implantation-us-based-pilot-study-100575393",false,"NCT06771700","S-ICD Implantation: US Based Pilot Study","Feasibility of an Intra-operative and Non-fluoroscopic Subcutaneous ICD Positioning and Assessment of the PRAETORIAN Score During Implantation: a Pilot Study","SUSTAIN S-ICD","Inclusion Criteria:\n\n* consecutive patients presenting for S-ICD implantation at our institution\n\nExclusion Criteria:\n\n* patients unable to consent.\n* pregnancy","ALL",{"count":72,"type":73},20,"ESTIMATED","INTERVENTIONAL",[76],"NA","This trial investigates two key aspects of the S-ICD implantation process. 1) For S-ICD implantation a pre-operative x-ray-based assessment of the anatomy and location of the heart is required. This study seeks to investigate the feasibility of US to potentially replace the need for x-ray 2) The PRAETORIAN score predicts defibrillation test success in subcutaneous ICD implantation but can only be calculated after the procedure. This pilot study aims to evaluate the feasibility of US determining the PRAETORIAN score intraoperatively. Lead-to-sternum distance and generator position measurments during the implantation procedure will be evaluated. Twenty consecutive patients scheduled for S-ICD implantation will be enrolled. The study involves no deviation from standard implantation procedures and requires no follow-up beyond standard post-operative chest X-ray on day one.",[79],"Sudden Cardiac Death",[81,82],"S-ICD","Defibrillator","2025-07-03",{"date":85,"type":86},"2025-07-09","ACTUAL",{"date":88,"type":86},"2025-03-01",{"date":90,"type":73},"2025-11-01",{"name":5,"class":6},2]