[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649762":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":47,"responsibleParty":102,"collaborators":25,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":25,"enrollmentInfo":114,"targetDuration":25,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":133,"whyStopped":25,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Hospital Clinic of Barcelona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Same-Day Discharge","EXPERIMENTAL","Participants randomized to the experimental arm will undergo a predefined same-day discharge pathway following successful transfemoral TAVI with the Medtronic Evolut PRO+\u002FFX\u002FFX+ system. Patients who remain clinically stable 6 hours after the procedure will be discharged on the same day after completion of the required clinical assessments and discharge education. A follow-up telephone assessment will be performed on the day after the procedure.",[13],"Other: Same-Day Discharge Strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard-of-Care Discharge","ACTIVE_COMPARATOR","Participants randomized to the control arm will receive standard inpatient post-procedural care and will be discharged according to local standard clinical practice (next-day or later discharge).",[19],"Other: Standard-of-Care Discharge Strategy",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Same-Day Discharge Strategy","Participants are discharged on the same day following successful transfemoral TAVI after confirmation of clinical stability 6 hours after the procedure. The discharge pathway includes standardized clinical assessment, patient and caregiver education, pre-discharge transthoracic echocardiography and blood testing, and a follow-up telephone assessment on the day after discharge.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard-of-Care Discharge Strategy","Participants receive routine post-procedural inpatient care following successful transfemoral TAVI and are discharged according to standard clinical practice (next-day or later discharge), with follow-up assessments performed according to the study protocol.",[15],[31],{"name":32,"affiliation":33,"role":34},"Josep Rodes-Cabau, Md, PhD","Institut universitaire de cardiologie et de pneumologie de Québec, University Laval","STUDY_DIRECTOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Ander Regueiro, MD","CONTACT","+34932275400","5519","AREGUEIR@clinic.cat",{"name":43,"role":38,"phone":44,"phoneExt":45,"email":46},"Emilie Pelletier Beaumont, Msc","1-418-656-8711","3929","emilie.pelletier-beaumont@criucpq.ulaval.ca",[48,71,85],{"facility":49,"status":25,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Institut Universitaire de cardiologie et de pneumologie de Quebec","Québec","Quebec","G1Y 3K4","Canada","CA",{"type":56,"coordinates":57},"Point",[58,59],-71.21454,46.81228,{"lat":59,"lon":58},[62,64,66,68],{"name":32,"role":38,"phone":44,"phoneExt":25,"email":63},"josep.rodes@criucpq.ulaval.ca",{"name":65,"role":38,"phone":44,"phoneExt":45,"email":46},"Emilie Pelletier Beaumont, MSc",{"name":32,"role":67,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":69,"role":70,"phone":25,"phoneExt":25,"email":25},"Anthony Poulin, Md","SUB_INVESTIGATOR",{"facility":72,"status":25,"city":73,"state":25,"zip":25,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Hospital Clínic de Barcelona","Barcelona","Spain","ES",{"type":56,"coordinates":77},[78,79],2.15899,41.38879,{"lat":79,"lon":78},[82],{"name":83,"role":38,"phone":84,"phoneExt":25,"email":41},"Ander Regueiro, Md, PhD","34 93 227 5400-2035",{"facility":86,"status":25,"city":87,"state":25,"zip":25,"country":74,"countryCode":75,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Hospital Universitario 12 de Octubre","Madrid",{"type":56,"coordinates":89},[90,91],-3.70256,40.4165,{"lat":91,"lon":90},[94,98],{"name":95,"role":38,"phone":96,"phoneExt":25,"email":97},"Jorge Nuche-Berenguer, Md, PhD","(+34) 619672813","jorge.nuche@salud.madrid.org",{"name":99,"role":38,"phone":100,"phoneExt":25,"email":101},"Carolina Andrade","(+34) 658 065 843","candrade.imas12@h12o.es",{"type":103,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100649762","same-day-versus-standard-hospital-discharge-after-tavi-home-tavi-100649762",false,"NCT07738575","Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)","HOspitalized Versus saME Day Discharge Transcatheter Aortic Valve Implantation (TAVI) With Self-expanding Valves. A Randomized Clinical Trial: The HOME-TAVI Trial","HOME-TAVI","Inclusion Criteria:\n\n* Adults (≥18 years of age)\n* Severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI\n* Treatment with the Medtronic Evolut PRO+, Evolut FX, Evolut FX+, or subsequent iterations\n* Successful TAVI procedure according to VARC-3 technical success criteria\n* Clinical stability 6 hours after TAVI\n* Written informed consent obtained before study participation\n\nExclusion Criteria:\n\n* Inability to ambulate independently at baseline\n* Hemodynamic or clinical instability before TAVI\n* Urgent or emergent TAVI procedure\n* Non-transfemoral access\n* Inadequate social support for discharge home\n* Inability to understand or comply with post-discharge instructions\n* Baseline right bundle branch block or high-grade atrioventricular block\n* Baseline left ventricular ejection fraction \\\u003C20%\n* Severe chronic kidney disease (estimated glomerular filtration rate : eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or dialysis).\n* Type 2-4 bleeding within 6 hours after TAVI\n* New-onset left bundle branch block or high-grade atrioventricular block within 6 hours after TAVI, unless a permanent pacemaker has already been implanted\n* New-onset atrial fibrillation within 6 hours after TAVI\n* Persistent hemodynamic instability within 6 hours after TAVI","ALL","18 Years",{"count":115,"type":116},764,"ESTIMATED","INTERVENTIONAL",[119],"NA","Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk. Advances in device technology and procedural techniques have enabled minimalist approaches and shorter hospital stays. Preliminary observational studies suggest that same-day discharge after TAVI may be feasible and safe in carefully selected patients, but randomized evidence remains limited, particularly in patients treated with self-expanding valves. The HOME-TAVI trial is a prospective, multicenter, international, randomized controlled trial designed to evaluate whether a same-day discharge strategy is non-inferior to standard hospital discharge after successful transfemoral TAVI with the Medtronic Evolut PRO+\u002FFX\u002FFX+ system. Eligible patients who remain clinically stable 6 hours after the procedure will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge.\n\nThe primary endpoint is a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include assessment of quality of life, patient-reported experience measures, healthcare resource utilization, and cost-effectiveness.",[122,123],"Aortic Stenosis, Severe","Aortic Stenosis",[125,126,127,9,128,129,130,131,132],"Transcatheter Aortic Valve Implantation (TAVI)","TAVI","TAVR","Early Discharge","Self-Expanding Valve","Evolut FX","Evolut FX+","Evolut PRO+","NOT_YET_RECRUITING","2026-07-27",{"date":136,"type":137},"2026-07-31","ACTUAL",{"date":139,"type":116},"2026-09-01",{"date":141,"type":116},"2029-06-01",{"name":5,"class":6},3]