[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639899":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":10,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Edwards Lifesciences","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Edwards KONECT RESILIA AVC",null,"Subjects who were treated with the Edwards KONECT RESILIA AVC",[13],"Device: Edwards KONECT RESILIA AVC",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","Surgical replacement of the aortic valve and ascending aorta with the Edwards KONECT RESILIA AVC",[9],[20],{"name":21,"affiliation":22,"role":23},"Markus Krane, Prof. Dr. med.","TUM Universitätsklinikum Deutsches Herzzentrum","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Sabrina Hundt, PhD","CONTACT","+49 (0)151 67550601","Sabrina_Hundt@edwards.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"TUM Klinikum Deutsches Herzzentrum","RECRUITING","München","Bavaria","80636","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],13.46314,48.69668,{"lat":43,"lon":42},[46],{"name":21,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":48,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100639899","konect-resilia-aortic-valved-conduit-avc-real-world-study-assessing-safety-and-performance-100639899",false,"NCT07619872","KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance","KONECTION","Inclusion Criteria:\n\n1. 18 years or older at the time of informed consent\n2. Have a diseased native or prosthetic aortic valve and a damaged or diseased ascending aorta that requires aortic valved conduit replacement surgery with the KONECT RESILIA AVC\n3. Provide written informed consent\n4. Willing to follow protocol requirements\n\nExclusion Criteria:\n\n1. Active endocarditis or endocarditis within 3 months prior to the study index procedure\n2. Emergency procedure\n3. Stage 4 renal disease (estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 excluded) or requiring dialysis\n4. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease in the opinion of the study investigator\n5. High predicted risk of mortality prior to the procedure: Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥8%","ALL","18 Years",{"count":59,"type":60},250,"ESTIMATED","OBSERVATIONAL","KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.",[64],"Aortic Valve Disease",[66],"Bentall","2026-07-16",{"date":69,"type":70},"2026-07-17","ACTUAL",{"date":72,"type":70},"2026-06-25",{"date":74,"type":60},"2039-06-30",{"name":5,"class":6},1]