[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480463":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":35,"responsibleParty":82,"collaborators":10,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":10,"enrollmentInfo":94,"targetDuration":97,"studyType":98,"phases":10,"briefSummary":99,"conditions":100,"keywords":110,"overallStatus":113,"whyStopped":10,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"JenaValve Technology, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Trilogy TAVI",null,"Patients receiving JenaValve Trilogy Heart Valve System for management of symptomatic, severe aortic stenosis (AS)\u002F aortic regurgitation (AR) who are at high risk for surgical aortic valve replacement (SAVR)",[13],"Device: Transcatheter Aortic Valve Implantation (TAVI)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Transcatheter Aortic Valve Implantation (TAVI)","TAVI with the JenaValve Trilogy Heart Valve System",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Stephan Baldus, MD","University Hospital of Cologne Heart Center","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Hendrik Treede, MD","Johannes Gutenberg University Mainz",[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Vinny Podichetty, Vice President: Clinical & Med Affairs","CONTACT","949-767-2110","1050","podichetty@jenavalve.com",[36,55,69],{"facility":37,"status":10,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen","Bad Oeynhausen","32545","Germany","DE",{"type":43,"coordinates":44},"Point",[45,46],8.80365,52.20699,{"lat":46,"lon":45},[49,53],{"name":50,"role":31,"phone":51,"phoneExt":10,"email":52},"Sarah Symank","+49 (0)5731-973442","ssymank@hdz-nrw.de",{"name":54,"role":24,"phone":10,"phoneExt":10,"email":10},"Tanja Rudolph, MD",{"facility":23,"status":10,"city":56,"state":10,"zip":57,"country":40,"countryCode":41,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Cologne","50937",{"type":43,"coordinates":59},[60,61],6.95,50.93333,{"lat":61,"lon":60},[64,68],{"name":65,"role":31,"phone":66,"phoneExt":10,"email":67},"Iris Berg","+49 221 4784191","iris.berg@uk-koeln.de",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":70,"status":10,"city":71,"state":10,"zip":72,"country":40,"countryCode":41,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University Hospital Mainz","Mainz","55131",{"type":43,"coordinates":74},[75,76],8.28008,49.98185,{"lat":76,"lon":75},[79,81],{"name":10,"role":31,"phone":80,"phoneExt":10,"email":10},"06131 17-3208",{"name":26,"role":24,"phone":10,"phoneExt":10,"email":10},{"type":83,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100480463","tavis-registry---trilogy-heart-valve-system-for-management-of-patients-with-aortic-valve-disease-100480463",false,"NCT05536310","TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease","Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study","TAVIS","Inclusion Criteria:\n\n1. Patients who have signed ICF and are indicated by their doctors to be treated with Trilogy Heart Valve System in line with the medical standard of care\n2. Patients with symptomatic severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are at high risk for SAVR as documented by the heart team and Heart Team agrees that patient can undergo SAVR for \"bail out\"\u002Fto address unfavorable circumstances if necessary\n3. Patients 18 years of age or older\n4. Patient is willing to participate in the study, provides signed Informed Consent\u002FData Authorization Form and authorizes the sharing of data in the study\n5. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Patients who have known hypersensitivity or contraindication to Nitinol (titanium and\u002For nickel), an anti-coagulation\u002Fanti-platelet regimen or contrast medium that cannot be managed with premedication\n2. Patients who have active bacterial endocarditis or other active infections\n3. Pediatric (\\\u003C18 years) and\u002For pregnant\u002Fnursing patients\n4. Congenital\u002Ffunctional unicuspid, bicuspid or quadricuspid native aortic valve morphology\n5. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\n6. Echocardiographic evidence of current left heart thrombus\n7. Hypertrophic cardiomyopathy with or without obstruction.\n8. Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter \\\u003C7mm.","ALL","18 Years",{"count":95,"type":96},600,"ESTIMATED","5 Years","OBSERVATIONAL","To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).",[101,102,103,104,105,106,107,108,109],"Aortic Valve Stenosis","Aortic Valve Regurgitation","Aortic Valve Stenosis With Insufficiency","Constriction, Pathologic","Aortic Valve Disease","Heart Valve Diseases","Cardiovascular Diseases in Old Age","Ventricular Outflow Obstruction","Aortic Stenosis, Severe",[111,105,112,102],"Trilogy","Transcatheter aortic valve replacement (TAVR)","NOT_YET_RECRUITING","2023-01-10",{"date":116,"type":117},"2023-01-11","ACTUAL",{"date":119,"type":96},"2023-03",{"date":121,"type":96},"2027-10",{"name":5,"class":6},3]