[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513531":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":26,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Medical University of Silesia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conduction System Pacing","EXPERIMENTAL","Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.",[13],"Device: conduction system pacing",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Pacing Method","ACTIVE_COMPARATOR","Patients who receive currently standard pacing method with exact type of ventricular pacing depending upon left ventricular ejection fraction (LVEF): right ventricular pacing in case of LVEF \\>= 40% or biventricular pacing if LVEF is determined to be less than 40%, as per current ESC guidelines.",[19],"Device: right ventricular or biventricular pacing",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","conduction system pacing","Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"right ventricular or biventricular pacing","Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.",[15],[32],{"name":33,"affiliation":34,"role":35},"Krzysztof S. Gołba, MD PhD","Silesian Medical University in Katowice","STUDY_CHAIR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+48 (32)359-88-93","krzysztof.golba@gmail.com",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},"Tomasz Soral, MD","tomasz.soral@gmail.com",[45],{"facility":46,"status":47,"city":48,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Medical University of Silesia in Katowice","RECRUITING","Katowice","Poland","PL",{"type":52,"coordinates":53},"Point",[54,55],19.02173,50.2597,{"lat":55,"lon":54},[58,60,61,64,66,68,70],{"name":33,"role":38,"phone":26,"phoneExt":26,"email":59},"k.golba@sum.edu.pl",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},{"name":62,"role":63,"phone":26,"phoneExt":26,"email":26},"Danuta Łoboda, MD, PhD","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":26,"phoneExt":26,"email":26},"Rafał Gardas, MD, PhD",{"name":67,"role":63,"phone":26,"phoneExt":26,"email":26},"Jolanta Biernat, MD, PhD",{"name":69,"role":63,"phone":26,"phoneExt":26,"email":26},"Grzegorz Jarosiński, MD, PhD",{"name":42,"role":63,"phone":26,"phoneExt":26,"email":26},{"type":72,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[74],{"name":75,"class":76},"Medical Research Agency, Poland","OTHER_GOV","100513531","physiologic-cardiac-pacing-to-prevent-left-ventricular-dysfunction-post-tavi-100513531",false,"NCT05966675","Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI","Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation","PACE-4-TAVI","Inclusion Criteria:\n\n1. transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation\n2. Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines\n3. Written informed consent\n4. Age of at least 18 years\n\nExclusion Criteria:\n\n1. Permanent pacemaker implantation before TAVI procedure\n2. The occurrence of conduction disturbances more than 30 days after TAVI procedure\n3. No written informed consent\n4. Inability to obtain informed consent from participant\n5. Predicted inability to obtain cooperation from patient during observation period","ALL","18 Years",{"count":88,"type":89},500,"ESTIMATED","INTERVENTIONAL",[92],"NA","The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).",[95],"Atrioventricular Block, Second and Third Degree",[97,98,99,100,101,102],"Pacemaker","Transcatheter Aortic Valve Replacement","Conduction System Pacing (CSP)","Atrioventricular Block","Congestive Heart Failure","Bradycardia","2025-06-04",{"date":105,"type":106},"2025-06-08","ACTUAL",{"date":108,"type":106},"2024-02-27",{"date":110,"type":89},"2028-06",{"name":5,"class":6},1]