[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633062":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":93,"collaborators":25,"id":96,"slug":25,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":25,"enrollmentInfo":105,"targetDuration":25,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":118,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"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",[37,51,64,74],{"facility":38,"status":39,"city":40,"state":25,"zip":25,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza","RECRUITING","Turin","Italy",{"type":43,"coordinates":44},"Point",[45,46],7.68682,45.07049,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":25,"phoneExt":25,"email":25},"Fabrizio D'Ascenzo, Professor of Medicine",{"facility":52,"status":39,"city":53,"state":25,"zip":25,"country":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland","Bialystok","Poland",{"type":43,"coordinates":56},[57,58],23.16433,53.13333,{"lat":58,"lon":57},[61],{"name":62,"role":33,"phone":25,"phoneExt":25,"email":63},"Łukasz Kuźma","kuzma.lukasz@gmail.com",{"facility":5,"status":39,"city":65,"state":25,"zip":66,"country":54,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Katowice","40-055",{"type":43,"coordinates":68},[69,70],19.02173,50.2597,{"lat":70,"lon":69},[73],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"facility":75,"status":76,"city":65,"state":25,"zip":77,"country":54,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland","NOT_YET_RECRUITING","40-635",{"type":43,"coordinates":79},[69,70],{"lat":70,"lon":69},[82,84,87,89,91],{"name":32,"role":33,"phone":83,"phoneExt":25,"email":35},"0048504827636",{"name":85,"role":86,"phone":25,"phoneExt":25,"email":25},"Wojciech Wańha, PhD","PRINCIPAL_INVESTIGATOR",{"name":88,"role":86,"phone":25,"phoneExt":25,"email":25},"Wojciech Wojakowski, Prof.",{"name":90,"role":86,"phone":25,"phoneExt":25,"email":25},"Grzegorz Smolka, Prof.",{"name":92,"role":86,"phone":25,"phoneExt":25,"email":25},"Krystian Wita, Prof.",{"type":86,"investigatorFullName":94,"investigatorTitle":95,"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":106,"type":107},250,"ESTIMATED","INTERVENTIONAL",[110],"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.",[113,114,115,116,117],"TAVI(Transcatheter Aortic Valve Implantation)","Remote Monitoring","Arrythmia","Atrial Fibrillation (AF)","Atrioventricular Block",[119,120,121],"TAVI","ECG","Monitoring","2026-04-07",{"date":124,"type":125},"2026-04-13","ACTUAL",{"date":127,"type":125},"2023-12-01",{"date":129,"type":107},"2028-02-01",{"name":5,"class":6},4]