[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499171":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":35,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Niguarda Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"TAVR performed with commissural alignment technique (Aligned Group)",null,"Patients with severe aortic stenosis undergoing TAVR procedure performed with commissural alignment technique. We consider in this groups only the Accurate and Accurate Neo 2 Valve which are the first choice due to the best stent frames position predictability with this technique",[13,14],"Procedure: TAVR Aligned","Procedure: TAVR Random",{"label":16,"type":10,"description":17,"interventionNames":18},"TAVR performed with random implantation of Navitor valve (Random Group)","Patients with severe aortic stenosis undergoing TAVR procedure performed with random implantation of Navitor Valve",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","TAVR Aligned","Investigate the feasibility of coronary re-engagement after commissural alignment technique in terms of success rate (%) and procedure complexity taking into account radiations, time and contrast used.",[9,16],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"TAVR Random","TAVR Random Feasibility comparison of coronary re-engagement between the randomly implanted Navitor valve (unaligned) and the others implanted with the commissural alignment technique in terms of success rate (%) and complexity of the procedure, taking into account radiation, time and contrast used",[9,16],[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Giuseooe Esposito, MD","CONTACT","+393278393131","giuseppe.esposito@yahoo.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"ASST GOM Niguarda","RECRUITING","Milan","Lombardy","20162","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],9.18951,45.46427,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":33,"phoneExt":10,"email":34},"Giuseppe Esposito, MD",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100499171","coronary-re-engagement-after-random-navitor-alignment-comfort-study-100499171",false,"NCT05779787","COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)","COronary Re-EngageMent aFter RandOm NavitoR Alignment (COMFORT STUDY)","COMFORT","Patients to be included in this registry should have all the following criteria:\n\n1\\. Severe, symptomatic aortic stenosis with an indication to TAVI\n\nExclusion criteria and definition\n\nPatients excluded in this registry should have all the following criteria:\n\n1. Valve in Valve procedure\n2. Hemodynamical instability\n3. TAVR performed from other access (not femoral)\n4. No-CT Planned TAVR\n5. TAVR performed with Chimney Technique","ALL","18 Years",{"count":66,"type":67},100,"ESTIMATED","OBSERVATIONAL","Whereas PCI before TAVR was previously recommended despite its uncertain prognostic role, recent data underline the possibility of a postponed coronary intervention using a commissural alignment technique. This approach allows easy coronary re-engagement through the valve stent frame with a trade off paid of procedure complexity.\n\nConsidering the prevalence of coronary artery disease (CAD) and the increasing percentage of younger patients treated with TAVI, investigate whether a simpler procedure with random implantation of Navitor valve is not inferior in terms of coronary re-access, is required The key point of the project will be the evaluation of the feasibility of coronary re-engagement after a Navitor valve randomly implanted.",[71,72],"Aortic Valve Stenosis","Transcatheter Aortic Valve Replacement","2026-04-13",{"date":75,"type":76},"2026-04-16","ACTUAL",{"date":78,"type":76},"2023-02-15",{"date":80,"type":67},"2027-05-15",{"name":5,"class":6},1]