[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616406":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":35,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":10,"enrollmentInfo":49,"targetDuration":52,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University Hospital of Patras","OTHER",[8,11,13],{"label":9,"type":10,"description":10,"interventionNames":10},"Concurrent BBAP + LBBP (total physiological pacing)",null,{"label":12,"type":10,"description":10,"interventionNames":10},"RAA pacing + LBBP",{"label":14,"type":10,"description":10,"interventionNames":10},"Conventional pacing (RAA + RV pacing)",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"GEORGIOS LEVENTOPOULOS","CONTACT","+306977786020","levent2669@gmail.com",[22],{"facility":23,"status":10,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":10},"University General Hospital of Patras","Pátrai","Achaia","26500","Greece","GR",{"type":30,"coordinates":31},"Point",[32,33],21.73508,38.2462,{"lat":33,"lon":32},{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Georgios Leventopoulos","Assistant Professor of Cardiology - Electrophysiology Patras University Hospital, Greece","100616406","study-of-ahre-burden-in-patients-undergoing-bachmann-bundle-area-pacing-and-left-bundle-branch-pacing-100616406",false,"NCT07305194","Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.","Study of Atrial High-Rate Episode Burden in Patients Undergoing Concurrent Bachmann Bundle Area Pacing and Left Bundle Branch Pacing , Compared With Either Left Bundle Branch Pacing or Conventional Right Ventricular Pacing.","AHRE-BLAST","Inclusion Criteria:\n\n* Adult patients (≥ 18 years) with a clear indication for permanent pacing, according to ESC guidelines \\[15\\] for the management of conduction disturbances (e.g. symptomatic bradycardia, complete atrioventricular block, sinus node dysfunction).\n* Sinus rhythm at the time of implantation, with no documented episodes of atrial fibrillation prior to implantation, either in the medical history or in previous recordings (ECG, Holter, telemetry).\n* Ability to be followed up for at least 24 months after implantation.\n* Provision of written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* History of atrial fibrillation prior to implantation, either permanent or paroxysmal, documented on ECG, Holter, or telemetry.\n* Prior pharmacological or interventional treatment for AF (e.g. antiarrhythmic drugs, catheter ablation).\n* Inability to comply with long-term follow-up or non-adherence to follow-up visits.\n* Contraindications to pacemaker lead placement at the selected sites.\n* Participation in another study that could influence the results.\n* Previous device implantation.","ALL","18 Years",{"count":50,"type":51},460,"ESTIMATED","24 Months","OBSERVATIONAL","This prospective observational study evaluates the burden of Atrial High-Rate Episodes (AHRE) in patients without a prior history of atrial fibrillation who undergo concurrent Bachmann Bundle Area Pacing (BBAP) and Left Bundle Branch Pacing (LBBP). Physiological pacing at these sites aims to improve interatrial conduction and reduce the risk of atrial arrhythmias.\n\nThe study includes a comparative assessment across three patient groups:\n\n1. BBAP + LBBP (physiological pacing group)\n2. Right Atrial Appendage (RAA) pacing + LBBP\n3. Conventional pacing - RAA and Right Ventricular (RV) pacing AHRE burden will be quantified via device diagnostics and remote monitoring at 3, 12 and 24 months post-implantation. Episodes will be classified by duration (0-6 min, 6-24 h, \\>24 h), differentiating subclinical AHRE from clinically documented AF.\n\nSecondary analyses include electrocardiographic changes (P-wave indices), the need for antiarrhythmic therapy, and comprehensive echocardiographic evaluation of atrial function (e.g., LA strain, conduction delays, LAVI).\n\nThe study aims to determine whether physiological pacing (BBAP + LBBP) provides superior protection against AHRE development compared with RAA + LBBP and conventional pacing strategies.",[56,57,58,59,60],"Atrial Arrhythmia","Atrial Fibrillation (AF)","Pacemaker Implantation","Left Bundle Branch Pacing","Conduction System Pacing",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77],"Atrial High-Rate Episodes (AHRE)","Subclinical Atrial Fibrillation","Bachmann Bundle Area Pacing (BBAP)","Left Bundle Branch Pacing (LBBP)","Physiological Pacing","Interatrial Conduction","Atrial Synchrony","P-wave Duration","Atrial Electromechanical Remodeling","Atrial Strain","Left Atrial Reservoir Strain","Inter-atrial Conduction Delay (IACD)","Speckle Tracking Echocardiography","Left Atrial Volume Index (LAVI)","Atrial Arrhythmias","Device-Detected AF","NOT_YET_RECRUITING","2025-12-11",{"date":81,"type":82},"2025-12-26","ACTUAL",{"date":84,"type":51},"2026-01-01",{"date":86,"type":51},"2028-04-14",{"name":5,"class":6},1]