[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577888":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":15,"armGroups":11,"interventions":16,"overallOfficials":11,"centralContacts":21,"locations":29,"responsibleParty":48,"collaborators":11,"id":52,"slug":11,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":11,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"University of Luebeck","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation",null,"5 Year",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":6,"timePerspective":14,"maskingInfo":11},"PROSPECTIVE","Patients who will be treated with Myval TAVR are included in the registry.",[17],{"type":18,"name":19,"description":20,"armGroupLabels":11,"otherNames":11},"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.",[22,27],{"name":23,"role":24,"phone":25,"phoneExt":11,"email":26},"Ingo Eitel, Prof. Dr.","CONTACT","004945150044542","cvro@uksh.de",{"name":28,"role":24,"phone":11,"phoneExt":11,"email":11},"Christian Frerker, PD Dr.",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Universitätsklinikum Schleswig-Holstein - Campus Lübeck","RECRUITING","Lübeck","Schleswig-Holstein","23538","Germany","DE",{"type":39,"coordinates":40},"Point",[41,42],10.68729,53.86893,{"lat":42,"lon":41},[45],{"name":28,"role":24,"phone":46,"phoneExt":11,"email":47},"045150044542","CVRO@uksh.de",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Prof. Dr. med. Ingo Eitel","Head of department of medical clinic II","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":61,"type":62},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.",[66],"Aortic Valve Stenosis","2025-01-27",{"date":69,"type":70},"2025-02-03","ACTUAL",{"date":72,"type":70},"2025-01-01",{"date":74,"type":62},"2030-12-30",{"name":50,"class":6},1]