[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598774":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":28,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"IRCCS Policlinico S. Donato","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"patients with symptomatic, severe, native aortic regurgitation",null,"patients with symptomatic, severe, native aortic regurgitation retrospectively or prospectively treated with TAVI JenaValve",[13],{"name":14,"affiliation":15,"role":16},"Luca Testa, PI","IRCCS Policlinico San Donato (San Donato Milanese) - IT","PRINCIPAL_INVESTIGATOR",[18,24],{"name":19,"role":20,"phone":21,"phoneExt":22,"email":23},"Federica Rossi, Study Coordinator","CONTACT","0252774984","0039","federica.rossi@grupposandonato.it",{"name":25,"role":20,"phone":26,"phoneExt":22,"email":27},"Mattia Ricotti, CET specialist","0252774236","mattia.ricotti@grupposandonato.it",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"IRCCS Policlinico San Donato","RECRUITING","San Donato Milanese","Milano","20097","Italy","IT",{"type":38,"coordinates":39},"Point",[40,41],9.26838,45.41047,{"lat":41,"lon":40},[44,45,47],{"name":19,"role":20,"phone":21,"phoneExt":22,"email":23},{"name":46,"role":20,"phone":26,"phoneExt":22,"email":27},"Mattia Ricotti",{"name":14,"role":16,"phone":10,"phoneExt":10,"email":10},{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100598774","the-artemis-data-collection-study-100598774",false,"NCT07075861","The ARTEMIS Data Collection Study","JenaValve Trilogy for Patients With Pure Native Aortic Valve Rigurgitation: the ARTEMIS Data Collection Study","ARTEMIS","Inclusion Criteria:\n\n* Considered at high or prohibitive risk for surgical aortic valve replacement by the Heart Team\n\n  * 18 years of age or older\n  * Suitable anatomy according to the IFU\n  * Absence of significant disease of the ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50mm or greater) or atheroma (especially if thick \\[\\>5mm\\], protruding or ulcerated)\n\nExclusion Criteria:\n\nThe JenaValve Trilogy Heart Valve System is contraindicated for use in 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, or who have active bacterial endocarditis or other active infections.\n\nThe JenaValve Trilogy Heart Valve System is contraindicated in those patients whose anatomy does not accommodate the System due to anatomical considerations outlined in the inclusion criteria.","ALL","18 Years",{"count":61,"type":62},75,"ESTIMATED","OBSERVATIONAL","To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection",[66],"Aortic Regurgitation Disease",[68,69,70],"JenaValve Trilogy","Aortic Regurgitation","TAVI","2025-12-17",{"date":73,"type":74},"2025-12-24","ACTUAL",{"date":76,"type":74},"2025-08-10",{"date":78,"type":62},"2028-08-10",{"name":5,"class":6},1]