[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554046":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":16,"armGroups":13,"interventions":17,"overallOfficials":13,"centralContacts":21,"locations":31,"responsibleParty":51,"collaborators":55,"id":58,"slug":13,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":13,"enrollmentInfo":66,"targetDuration":13,"studyType":69,"phases":13,"briefSummary":20,"conditions":70,"keywords":13,"overallStatus":34,"whyStopped":13,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University of Luebeck","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Time until first occurrence","* Stroke including ischemic or hemorrhagic stroke,\n* Systemic embolism,\n* Major bleeding (BARC type 3-5), or Cardiovascular or unexplained death","30 Days",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":6,"timePerspective":15,"maskingInfo":13},"PROSPECTIVE","Patients who were treated with Myval TAVR via TAX access are included in the registry.\n\nThe participating centers also provide a retrospective cohort of TAX-TAVR implantations with other TAVR prothesis (e.g. Edwards Sapien XT\u002F3\u002FUltra, Medtronic Evolut R\u002FPro, Accurate Neo, Allegra, Portico) to compare the results and outcomes of the MYVAL-TAX-TAVR registry using the Myval THV with other TAVR bioprothesis used for TAX-TAVR. To further improve comparability between groups propensity score matching between the groups will be performed using the following parameters (age, sex, STS score, peripheral artery disease, atrial fibrillation, minimum axillary diameter, moderate\u002Fsevere axillary tortuosity and moderate\u002Fsevere axillary, calcification).",[18],{"type":6,"name":19,"description":20,"armGroupLabels":13,"otherNames":13},"transaxillary (TAX) transcatheter aortic valve replacement","Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).",[22,27],{"name":23,"role":24,"phone":25,"phoneExt":13,"email":26},"Ingo Eitel, Prof. Dr.","CONTACT","+49451500444501","ingo.eitel@uksh.de",{"name":28,"role":24,"phone":29,"phoneExt":13,"email":30},"Roza Saraei, Dr.","+4945150044542","roza.saraei@uksh.de",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Universität zu Lübeck","RECRUITING","Lübeck","Schleswig-Holstein","23538","Germany","DE",{"type":41,"coordinates":42},"Point",[43,44],10.68729,53.86893,{"lat":44,"lon":43},[47,49],{"name":48,"role":24,"phone":13,"phoneExt":13,"email":13},"Ingo Eitel, Prof. Dr. med.",{"name":50,"role":24,"phone":13,"phoneExt":13,"email":13},"Thomas Stiermaier, Prof. Dr. med.",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Prof. Dr. med. Ingo Eitel","Head of the MKII",[56],{"name":57,"class":6},"University Hopsital Schleswig Holstein Campus Lübeck","100554046",false,"NCT06493994","Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry","MYVAL-TAX-TAVR","Inclusion Criteria:\n\n* Patient has been treatet transaxillary (TAX) with Myval transcatheter aortic valve replacement\n* BMI \\\u003C35 kg\u002Fm2\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* History of coronary artery bypass graft and a patent left internal mammary artery (LIMA)\n* Age ≤18 years\n* Patients presenting with pregnancy\n* Patients without informed consent\n* Expected life expectancy \\\u003C2 years","ALL","18 Years",{"count":67,"type":68},100,"ESTIMATED","OBSERVATIONAL",[71],"Aortic Valve Stenosis","2025-01-02",{"date":74,"type":75},"2025-01-03","ACTUAL",{"date":77,"type":75},"2025-01-01",{"date":79,"type":68},"2027-01-30",{"name":5,"class":6},1]