[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608423":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":47,"locations":53,"responsibleParty":66,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":10,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":10,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Clinical Hospital Center Rijeka","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"The group with new-onset TAVI-related conduction disorders (CDs)",null,"The group will include patients with new-onset CD or PPI detected during the index hospitalization and a 3-month follow-up period.",[13,14],"Diagnostic Test: Biomarkers of inflammation and fibrosis in pre-procedural serum blood samples","Diagnostic Test: Transthoracic echocardiography with myocardial deformation analysis and staging according to the extent of cardiac damage related to AS",{"label":16,"type":10,"description":17,"interventionNames":18},"The group without new-onset TAVI-related conduction disorders (CDs)","The group will include patients without new-onset CD or PPI detected during the index hospitalization and a 3-month follow-up period.",[13,14],[20,36],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Biomarkers of inflammation and fibrosis in pre-procedural serum blood samples","In all patients, peripheral venous blood samples will be collected before the TAVI procedure for analysis and calculation of prespecified inflammatory and fibrosis biomarkers. In a subpopulation of 40 individuals, four specific microRNAs (miR-21, miR-29b, miR-155, and miR-146b) will be additionally analysed. The level of each biomarker will be correlated with rates of new-onset TAVI-related CDs and compared between patients with detected and patients without detected new-onset CDs.",[9,16],[26,27,28,29,30,31,32,33,34,35],"C-reactive protein (CRP)","Procalcitonin (PCT)","Interleukin-6 (IL-6)","CRP\u002Falbumin ratio (CAR)","Index of Systemic Immuno-inflammation (SII)","Lactate-dehydrogenase (LD)","Micro ribonucleic acids (miRNAs)","Ferritin","Transforming Growth Factor-β1 (TGF-β1)","Calprotectin",{"type":21,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Transthoracic echocardiography with myocardial deformation analysis and staging according to the extent of cardiac damage related to AS","The echocardiographic stage of extravalvular cardiac damage related to AS and myocardial deformation parameters will be analysed in each patient before TAVI procedure and compared between the group with detected new-onset CDs and the group without new-onset CDs with a goal to examine their predictive value for the development of TAVI-related CDs.",[9,16],[41,42,43,44,45,46],"Stage of extravalvular cardiac damage related to AS","Left ventricle global longitudinal strain (LV GLS)","LV apical to basal strain ratio","Right ventricle global longitudinal strain (RV GLS)","Right ventricle free wall strain (RV FWS)","Myocardial work index (MWI)",[48],{"name":49,"role":50,"phone":51,"phoneExt":10,"email":52},"Gordana Bačić, MD","CONTACT","+38551407320","gordana.bacic@uniri.hr",[54],{"facility":5,"status":55,"city":56,"state":57,"zip":58,"country":57,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":10},"RECRUITING","Rijeka","Croatia","51000","HR",{"type":61,"coordinates":62},"Point",[63,64],14.44241,45.32673,{"lat":64,"lon":63},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Gordana Bacic","Principal Investigator",[71],{"name":72,"class":73},"University of Rijeka, Medical Faculty","UNKNOWN","100608423","biomarkers-of-inflammation-and-fibrosis-in-conduction-disorders-after-tavi-100608423",false,"NCT07201363","Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI","The Role of Inflammation and Fibrosis in the Development of Conduction Disorders After Transcatheter Aortic Valve Implantation","Inclusion Criteria:\n\n* Written consent to participate in the trial\n* Diagnosis of severe AS according to current European Society of Cardiology (ESC) guidelines for valvular heart disease\n\nExclusion Criteria:\n\n* Acute infectious disease\n* Chronic inflammatory or autoimmune disease\n* Corticosteroid or other immunosuppressive therapy\n* Active malignant disease\n* Liver disease accompanied by dysfunction\n* Permanent pacemaker implanted previously\n* An acute myocardial infarction within three months before the procedure\n* A surgical procedure within three months before the procedure\n* Previous surgical or transcatheter aortic valve replacement\u002Fimplantation\n* End-stage chronic kidney disease (eGFR \\\u003C15 ml\u002Fmin)",true,"ALL","18 Years",{"count":85,"type":86},102,"ESTIMATED","OBSERVATIONAL","Prediction of conduction disorders (CDs) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) is an important and complex process with a significant impact on patient outcomes. The goal of this observational prospective trial is to investigate the role of pre-procedural values of systemic biomarkers of inflammation and fibrosis in the prediction of new-onset CDs and permanent pacemaker implantation (PPI) in patients undergoing the TAVI procedure.",[90,91,92,93],"TAVI(Transcatheter Aortic Valve Implantation)","Conduction Disorder","Aortic Stenosis","Permanent Pacemaker Implantation",[92,95,91,96,97,98],"Biomarkers","Fibrosis","Inflammation","Transcatheter Aortic Valve Implantation","2025-09-30",{"date":101,"type":102},"2025-10-06","ACTUAL",{"date":104,"type":102},"2024-12-12",{"date":106,"type":86},"2026-08",{"name":5,"class":6},1]