[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577888":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":21,"responsibleParty":40,"collaborators":7,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":7,"enrollmentInfo":53,"targetDuration":7,"studyType":56,"phases":7,"briefSummary":57,"conditions":58,"keywords":7,"overallStatus":24,"whyStopped":7,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"University of Luebeck","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Myval Transcatheter Heart Valve","The Myval TAVR bioprothesis is a balloon-expandable THV developed by Meril Lifesciences, which has novel operator friendly design features to improve deliverability and aid precise deployment.",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Ingo Eitel, Prof. Dr.","CONTACT","004945150044542","cvro@uksh.de",{"name":20,"role":16,"phone":7,"phoneExt":7,"email":7},"Christian Frerker, PD Dr.",[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Universitätsklinikum Schleswig-Holstein - Campus Lübeck","RECRUITING","Lübeck","Schleswig-Holstein","23538","Germany","DE",{"type":31,"coordinates":32},"Point",[33,34],10.68729,53.86893,{"lat":34,"lon":33},[37],{"name":20,"role":16,"phone":38,"phoneExt":7,"email":39},"045150044542","CVRO@uksh.de",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","Prof. Dr. med. Ingo Eitel","Head of department of medical clinic II","100577888","myval-transcatheter-heart-valve-system---prospective-german-multicenter-registry-100577888",false,"NCT06804148","MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry","German MYVAL S","Inclusion Criteria:\n\n* Patient is going to be treated with Myval THV\n* Age ≥ 18 years\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Pregnant and lactating women\n* Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.\n* Patients in whom anti-platelet and\u002For anticoagulant therapy are contra-indicated.\n* Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the registry","ALL","18 Years",{"count":54,"type":55},2000,"ESTIMATED","OBSERVATIONAL","Rational of the Myval THV - Prospective German Multicenter Registry is to evaluate the performance of this relatively new but very promising TAVR valve in a consecutive real-word, all-comers registry and to assess the long-term durability and efficacy of the Myval THV.",[59],"Aortic Valve Stenosis","2025-01-27",{"date":62,"type":63},"2025-02-03","ACTUAL",{"date":65,"type":63},"2025-01-01",{"date":67,"type":55},"2030-12-30",{"name":42,"class":6},1]