[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553057":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":62,"collaborators":65,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":25,"enrollmentInfo":94,"targetDuration":25,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Institut d'Investigació Biomèdica de Bellvitge","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Positive initial (3-7 days following TAVI) electrophysiological study (EP+)","EXPERIMENTAL","Permanent pacemaker implantation. Continuous ECG monitoring during 4 weeks. Second EP study 30-45 days after TAVI.",[13,14],"Diagnostic Test: Electrophysiological study (EP study)","Diagnostic Test: ePatch (extended Holter Monitoring)",{"label":16,"type":6,"description":17,"interventionNames":18},"Negative initial (3-7 days following TAVI) electrophysiological study (EP-)","Continuous ECG monitoring during 4 weeks.",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Electrophysiological study (EP study)","Electrophysiological study: A second EP study 30-45 days after TAVI will be performed in the group of patients with positive EP study 3-7 days after TAVI.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"ePatch (extended Holter Monitoring)","Continuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI",[16,9],[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Guillem Muntané Carol, MD, PhD","CONTACT","+342607500","7539","gmuntanec@bellvitgehospital.cat",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Hospital Universitari de Bellvitge","RECRUITING","L'Hospitalet de Llobregat","Barcelona","08097","Spain","ES",{"type":47,"coordinates":48},"Point",[49,50],2.10028,41.35967,{"lat":50,"lon":49},[53,55,57,60],{"name":39,"role":33,"phone":34,"phoneExt":35,"email":54},"uac@bellvitgehospital.cat",{"name":32,"role":56,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":58,"role":59,"phone":25,"phoneExt":25,"email":25},"Andrea di Marco, MD, PhD","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":25,"phoneExt":25,"email":25},"Julián Rodríguez García, MD",{"type":56,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Guillem Muntané Carol","Principal Investigator",[66,67,69,71,73,76,78,80,82],{"name":39,"class":6},{"name":68,"class":6},"Hospital Universitario La Paz",{"name":70,"class":6},"Hospital Vall d'Hebron",{"name":72,"class":6},"Hospital Universitario Ramon y Cajal",{"name":74,"class":75},"Hospital Universitario A Coruna Spain","UNKNOWN",{"name":77,"class":6},"Hospital Clinico Universitario de Santiago",{"name":79,"class":6},"Hospital Universitario Central de Asturias",{"name":81,"class":6},"Hospital Universitario Marqués de Valdecilla",{"name":83,"class":6},"Hospital Clínico Universitario de Valladolid","100553057","reversibility-of-cardiac-conduction-disturbances-following-tavi-100553057",false,"NCT06481137","Reversibility of Cardiac Conduction Disturbances Following TAVI","InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study","TAVI-REVERSE","Inclusion Criteria:\n\n* Patients with indication for electrophysiological (EP) study after TAVI implantation according to European Guidelines. Patients must have persistent electrocardiographic conduction disturbances (ECG-CDs) that are present from day 2 after TAVI implantation (≥ 48h post-procedure):\n* De novo LBBB with QRS complex \\>150ms and\u002For PR interval ≥240ms.\n* QRS widening or post-procedural PR lengthening \\> 20ms in patients with baseline ECG-CDs.\n\nExclusion Criteria:\n\n* Patients with previous pacemaker or implantable defibrillator.\n* Patients with baseline complete right bundle branch block.\n* Patients in need of cardiac resynchronization or physiological stimulation following TAVI.\n* Valve-in-valve procedures.\n* TAVI procedures in patients with severe aortic insufficiency.\n* Inability to sign the informed consent form.","ALL","18 Years",{"count":95,"type":96},209,"ESTIMATED","INTERVENTIONAL",[99],"NA","The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block.\n\nIn this study, the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study (EPS) 3-7 days following TAVI. In addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI.\n\nIn this multicenter, longitudinal, prospective study, patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included. A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days. Additionally, these patients will undergo 4-week continuous monitoring using the ePatch (Philips) long-term Holter recorder, to identify episodes of paroxysmal complete atrioventricular block. Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks.",[102,103,104],"Aortic Stenosis","Transcatheter Aortic Valve Implantation","Conduction Disturbances",[106,103,104],"Aortic stenosis","2024-06-25",{"date":109,"type":110},"2024-07-01","ACTUAL",{"date":112,"type":110},"2024-06-17",{"date":114,"type":96},"2026-12-31",{"name":5,"class":6},1]