[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633062":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":95,"collaborators":25,"id":98,"slug":25,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":25,"enrollmentInfo":107,"targetDuration":25,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":120,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Medical University of Silesia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Remote ECG monitoring","EXPERIMENTAL","Device: continuous 30-day ECG monitoring with visits triggered by ECG findings",[13],"Device: Remote ECG monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","ACTIVE_COMPARATOR","Control group, which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days",[19],"Device: Standard Care (in control arm)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Patients will be randomized to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and the control group (which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days).",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Care (in control arm)","Description: Patients will be randomized to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and the control group (which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days).",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Wojciech Wańha, MD, PhD","CONTACT","504827636","wojciech.wanha@gmail.com",[37,52,66,76],{"facility":38,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza","RECRUITING","Turin","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],7.68682,45.07049,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":25,"phoneExt":25,"email":25},"Fabrizio D'Ascenzo, Professor of Medicine",{"facility":53,"status":39,"city":54,"state":25,"zip":25,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland","Bialystok","Poland","PL",{"type":44,"coordinates":58},[59,60],23.16433,53.13333,{"lat":60,"lon":59},[63],{"name":64,"role":33,"phone":25,"phoneExt":25,"email":65},"Łukasz Kuźma","kuzma.lukasz@gmail.com",{"facility":5,"status":39,"city":67,"state":25,"zip":68,"country":55,"countryCode":56,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Katowice","40-055",{"type":44,"coordinates":70},[71,72],19.02173,50.2597,{"lat":72,"lon":71},[75],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"facility":77,"status":78,"city":67,"state":25,"zip":79,"country":55,"countryCode":56,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland","NOT_YET_RECRUITING","40-635",{"type":44,"coordinates":81},[71,72],{"lat":72,"lon":71},[84,86,89,91,93],{"name":32,"role":33,"phone":85,"phoneExt":25,"email":35},"0048504827636",{"name":87,"role":88,"phone":25,"phoneExt":25,"email":25},"Wojciech Wańha, PhD","PRINCIPAL_INVESTIGATOR",{"name":90,"role":88,"phone":25,"phoneExt":25,"email":25},"Wojciech Wojakowski, Prof.",{"name":92,"role":88,"phone":25,"phoneExt":25,"email":25},"Grzegorz Smolka, Prof.",{"name":94,"role":88,"phone":25,"phoneExt":25,"email":25},"Krystian Wita, Prof.",{"type":88,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Wojciech Wańha","MD, PhD, Prof.","100633062",false,"NCT07521800","Remote ECG Monitoring Post TAVI","Remote ECG Monitoring as a Diagnostic Tool for Therapeutic Strategies After Transcatheter Aortic Valve Replacement: Rationale and Design of the DRAGON-TAVI Trial.","DRAGON-TAVI","Inclusion Criteria:\n\n* Patient age over 18 years old\n* Severe aortic stenosis\n* Moderate or high cardiovascular risk based on current ESC Guidelines \"Heart Team\" qualification for TAVI\n* Written informed consent of the patient for participation in the study\n\nExclusion Criteria:\n\n* History of atrial fibrillation or atrial flutter\n* Previously known conduction disturbances\\*\\*\n* Presence of: pacemaker, CRT-P, ICD, CRT-D before or after TAVI\n* Ischaemic stroke, TIA, MI or heart surgery within 1 month before TAVI qualification\n* Haemorrhagic stroke within 1 year before TAVI qualification\n* Chronic immunosuppressive therapy\n* Comorbidities (e.g. drug addiction, alcohol abuse, emotional\u002Fmental disorders) which do not allow safe participation in the study","ALL","18 Years",{"count":108,"type":109},250,"ESTIMATED","INTERVENTIONAL",[112],"NA","The DRAGON TAVI study is a multicenter, prospective, open, randomised trial, which will enrol 250 patients, randomized 1:1 to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and standard care (ie. control group, which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days). The duration of the study is 12 months ± 1 month.",[115,116,117,118,119],"TAVI(Transcatheter Aortic Valve Implantation)","Remote Monitoring","Arrythmia","Atrial Fibrillation (AF)","Atrioventricular Block",[121,122,123],"TAVI","ECG","Monitoring","2026-04-07",{"date":126,"type":127},"2026-04-13","ACTUAL",{"date":129,"type":127},"2023-12-01",{"date":131,"type":109},"2028-02-01",{"name":5,"class":6},4]