[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490545":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":37,"responsibleParty":54,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":18,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"LMU Klinikum","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transesophageal echocardiography + fluoroscopy guided lead implantation","EXPERIMENTAL","TEE will be done in addition to fluoroscopy to guide lead implantation.",[13],"Procedure: Additional guidance of lead implantation by transesophageal echocardiography",{"label":15,"type":16,"description":17,"interventionNames":18},"Fluoroscopy guided lead implantation","NO_INTERVENTION","Fluoroscopy only will be used to guide lead implantation.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Additional guidance of lead implantation by transesophageal echocardiography","Transesophageal echocardiography guidance of lead implantation targeting a stable lead position in a tricuspid valve commissure (preferentially postero-septal) and an apical ventricular lead position",[9],[26],{"name":27,"affiliation":5,"role":28},"Daniel Braun, MD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+4989440072371","daniel.braun@med.uni-muenchen.de",{"name":35,"role":31,"phone":32,"phoneExt":18,"email":36},"Jonas Gmeiner, MD","jonas.gmeiner@med.uni-muenchen.de",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Munich","Bavaria","81377","Germany","DE",{"type":46,"coordinates":47},"Point",[48,49],11.57549,48.13743,{"lat":49,"lon":48},[52],{"name":53,"role":31,"phone":18,"phoneExt":18,"email":18},"Daniel Braun, Prof. Dr.",{"type":28,"investigatorFullName":27,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Senior attending physician department of cardiology, principal investigator","100490545","prevention-of-pacemaker-lead-induced-tricuspid-regurgitation-by-transesophageal-echo-guided-implantation-place-100490545",false,"NCT05667519","Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)","PLACE","Inclusion Criteria:\n\n* indication for right ventricular lead implantation according to current guidelines\n\nExclusion Criteria:\n\n* preexisting tricuspid regurgitation ≥ grade 2\n* other severe heart valve disease\n* history of tricuspid valve treatment\n* preexisting right ventricular lead\n* chronic dialysis\n* contraindication for transesophageal echocardiography","ALL","18 Years",{"count":66,"type":67},324,"ESTIMATED","INTERVENTIONAL",[70],"NA","This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.",[73,74],"Tricuspid Regurgitation","Pacemaker Complication","2022-12-19",{"date":77,"type":78},"2022-12-28","ACTUAL",{"date":80,"type":78},"2022-10-01",{"date":82,"type":67},"2027-10",{"name":5,"class":6},1]