[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637150":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":84,"collaborators":87,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":25,"maxAge":25,"enrollmentInfo":99,"targetDuration":25,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":59,"whyStopped":25,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University Hospital of Ferrara","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TAVI in center without on-site cardiac surgery","EXPERIMENTAL","Participants assigned to this arm will undergo transcatheter aortic valve implantation in a participating center without on-site cardiac surgery. The procedure will be performed by experienced TAVI operators according to current guidelines, institutional standards, and pre-procedural Heart Team assessment. Participating centers must have appropriate imaging, procedural expertise, and predefined pathways for rapid transfer to a referral cardiac surgery center if needed.",[13],"Procedure: Transcatheter Aortic Valve Implantation",{"label":15,"type":16,"description":17,"interventionNames":18},"TAVI in center with on-site cardiac surgery","ACTIVE_COMPARATOR","Participants assigned to this arm will undergo transcatheter aortic valve implantation in a center with on-site cardiac surgery. After randomization, patients will be referred to the collaborating cardiac surgery center and treated according to the local waiting list and standard clinical practice. The procedure will be performed by experienced TAVI operators in accordance with current guidelines, institutional standards, and pre-procedural Heart Team assessment.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Transcatheter Aortic Valve Implantation","Transcatheter aortic valve implantation is performed as the study procedure in patients with severe aortic stenosis and an indication for TAVI confirmed by the multidisciplinary Heart Team. The procedure is performed according to current guidelines and institutional standards by experienced TAVI operators. In this trial, the intervention is evaluated according to the setting in which it is performed: either in a center without on-site cardiac surgery or in a center with on-site cardiac surgery.",[15,9],null,[27],{"name":28,"affiliation":5,"role":29},"Gianluca Campo, MD","PRINCIPAL_INVESTIGATOR",[31,36],{"name":28,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","0532236450","+39","cmpglc@unife.it",{"name":37,"role":32,"phone":38,"phoneExt":34,"email":39},"Alice Santoni","0532 237858","alice27santoni@gmail.com",[41,57,71],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Azienda Ospedaliero Universitaria di Ferrara","NOT_YET_RECRUITING","Ferrara","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],11.62057,44.83804,{"lat":51,"lon":50},[54],{"name":55,"role":32,"phone":56,"phoneExt":34,"email":35},"Gianluca, Campo","0532236269",{"facility":58,"status":59,"city":60,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Ospedale di Mirano","RECRUITING","Mirano",{"type":48,"coordinates":62},[63,64],12.10775,45.49458,{"lat":64,"lon":63},[67],{"name":68,"role":32,"phone":69,"phoneExt":34,"email":70},"Salvatore Saccà","041\u002F5794158","salvatore.sacca@aulss3.veneto.it",{"facility":72,"status":59,"city":73,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Ospedale Ss. Giovanni e Paolo","Venezia",{"type":48,"coordinates":75},[76,77],11.17365,44.42329,{"lat":77,"lon":76},[80],{"name":81,"role":32,"phone":82,"phoneExt":34,"email":83},"Giuseppe Grassi","041 529 4111","giuseppe.grassi@aulss3.veneto.it",{"type":29,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Gianluca Campo","Full Professor of Cardiology",[88],{"name":89,"class":6},"Consorzio Futuro in Ricerca","100637150","transcatheter-aortic-valve-implantation-without-on-site-cardiac-surgery-100637150",false,"NCT07604402","TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery","TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery Broadened Access","TRACS-PRIME","Inclusion criteria\n\n1. Severe aortic stenosis\n2. Indication to TAVI confirmed by the Heart Team\n\nAND one of the following enrichment criteria:\n\n1. Prohibitive operative risk\n2. High surgical risk as defined as STS score \\>8%\n3. Porcelain aorta or severely atherosclerotic aorta\n4. Frailty\u002FReduced physical performance\n5. Severe liver disease\u002Fcirrhosis\n6. Hostile chest and\u002For internal mammalian artery or other critical conduit(s) crossing midline and\u002For adhering to the posterior table of the sternum\n7. Severe pulmonary hypertension and\u002For severe right ventricular dysfunction\n8. Age ≥85 years\n9. Severe Chronic Obstructive Pulmonary Disease (COPD) The criteria listed above qualify the patient for eligibility in the study if present immediately after the heart team has indicated TAVI. However, this does not exclude patients without these criteria from entering the study if the heart team's evaluation still considers their risk\u002Fbenefit profile appropriate for inclusion in the protocol.\n\nExclusion criteria\n\n1. Unsuitable for transfemoral TAVI\n2. Emergent TAVI\n3. Non-cardiovascular comorbidity reducing life expectancy to \\\u003C1 year\n4. Any factor precluding 1-year follow-up\n5. Refusal of informed consent","ALL",{"count":100,"type":101},1612,"ESTIMATED","INTERVENTIONAL",[104],"NA","TRACS-PRIME is a prospective, randomized, multicenter clinical trial evaluating whether transcatheter aortic valve implantation (TAVI) can be performed safely and effectively in selected hospitals without on-site cardiac surgery, when appropriate patient selection, experienced operators, advanced imaging, and established transfer pathways are available. The study will include patients with severe symptomatic aortic stenosis who have an indication for TAVI confirmed by a multidisciplinary Heart Team. Eligible patients will be randomized to undergo TAVI either in a center without on-site cardiac surgery or in a center with on-site cardiac surgery. All procedures will be performed according to current standards of care by experienced TAVI operators. The main purpose of the study is to determine whether TAVI performed in centers without on-site cardiac surgery is not inferior to TAVI performed in centers with on-site cardiac surgery with respect to clinical outcomes at 1 year. The primary clinical outcome includes death from any cause, stroke, or hospitalization related to the procedure or the implanted valve. The study will also assess safety outcomes, including valve-related death and major procedural or technical complications. Participants will be followed after hospital discharge to assess clinical events, safety, and longer-term outcomes. An independent committee blinded to treatment allocation will review clinical events, and an independent Data Safety Monitoring Board will monitor patient safety during the trial.",[107],"Aortic Stenosis",[109,110],"TAVI","on-site cardiac surgery","2026-05-26",{"date":113,"type":114},"2026-05-29","ACTUAL",{"date":116,"type":114},"2026-05-25",{"date":118,"type":101},"2034-05-25",{"name":5,"class":6},3]