[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100331853":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":9,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":22,"enrollmentInfo":68,"targetDuration":22,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":39,"whyStopped":22,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Deutsches Herzzentrum Muenchen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TriRec","EXPERIMENTAL","Trileaflet Reconstruction of the Aortic Valve",[13],"Other: TriRec",{"label":15,"type":10,"description":16,"interventionNames":17},"Aortic valve replacement","Biological prosthesis, Device: St. Jude Medical Trifecta GT",[18],"Other: Aortic valve replacement",[20,23],{"type":6,"name":9,"description":11,"armGroupLabels":21,"otherNames":22},[9],null,{"type":6,"name":15,"description":24,"armGroupLabels":25,"otherNames":22},"Biological Prosthesis, Device: St. Jude Medical Trifecta GT",[15],[27],{"name":28,"affiliation":29,"role":30},"Markus Krane, MD, PhD","Department of Cardiovascular Surgery, German Heart Center Munich","STUDY_CHAIR",[32],{"name":28,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","+4989-1218","4111","krane@dhm.mhn.de",[38],{"facility":29,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Munich","Bavaria","80336","Germany","DE",{"type":46,"coordinates":47},"Point",[48,49],11.57549,48.13743,{"lat":49,"lon":48},[52],{"name":28,"role":33,"phone":34,"phoneExt":53,"email":36},"-4111",{"type":55,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[57],{"name":29,"class":58},"UNKNOWN","100331853","trirec---trileaflet-reconstruction-of-the-aortic-valve-with-autologous-pericardium-100331853",false,"NCT03600662","TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium","TriRec - Trileaflet Reconstruction of the Aortic Valve","Inclusion Criteria:\n\n* Age \\>= 50 years\n* Documented symptomatic moderate or greater aortic stenosis or severe insufficiency\n* Aortic annulus \\> 19 mm\n* Written informed consent of the patient.\n\nExclusion Criteria:\n\n* Concomitant intervention of the aortic root\n* Concomitant intervention of the aortic arch\n* Concomitant valve surgery\n* Emergency surgery for any reason\n* Neurological events (i.e. stroke, TIA) within 6 months preoperatively\n* Coagulation disorders (including thrombocytopenia \\\u003C 100.000\u002Fml)\n* Porcelain aorta\n* Active endocarditis or other active systemic infections\n* Participating in another trial that may influence the outcome of this trial\n* Pregnancy\n* Dual antiplatelet therapy\n* Previous cardiac surgery (excluding percutaneous procedures)","ALL","50 Years",{"count":69,"type":70},128,"ESTIMATED","INTERVENTIONAL",[73],"NA","Reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (EOA) to surgical aortic valve replacement (SAVR) with a biological prosthesis (St. Jude Trifecta GT) as gold- standard.",[76],"Alternative Surgical Treatment for Aortic Valve Disease",[78,79,80,81,82],"aortic stenosis","aortic regurgitation","Trileaflet reconstruction of the aortic valve","Biological aortic valve prosthesis","Effective orifice area","2018-07-16",{"date":85,"type":86},"2018-07-26","ACTUAL",{"date":88,"type":86},"2018-01-18",{"date":90,"type":70},"2030-01",{"name":5,"class":6},1]