[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639899":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":10,"id":48,"slug":10,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":10,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"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":10,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"TUM Klinikum Deutsches Herzzentrum","München","Bavaria","80636","Germany","DE",{"type":39,"coordinates":40},"Point",[41,42],13.46314,48.69668,{"lat":42,"lon":41},[45],{"name":21,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":57,"type":58},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.",[62],"Aortic Valve Disease",[64],"Bentall","NOT_YET_RECRUITING","2026-05-26",{"date":68,"type":69},"2026-06-02","ACTUAL",{"date":71,"type":58},"2026-06-30",{"date":73,"type":58},"2039-06-30",{"name":5,"class":6},1]