[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612203":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":56,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University Hospital of Patras","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Conventional Right Ventricular Pacing","ACTIVE_COMPARATOR","Procedure: Standard right ventricular septal pacing\n\nDescription: Implantation of a dual-chamber pacemaker with the ventricular lead placed in the RV septum.\n\nAt follow-up, the ventricular pacing percentage and pacing configuration will be noted.",[13],"Device: Right Ventricular Pacing",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: Left Bundle Branch Pacing (LBBP)","Procedure: Left bundle branch pacing lead implantation\n\nDescription: Implantation of a dual-chamber pacemaker with the ventricular lead placed at the left bundle branch area.\n\nPhysiological pacing will be programmed into the devices and, at follow-up, the percentage of spontaneous pacing will be noted.",[18],"Device: Left Bundle Branch Pacing",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Right Ventricular Pacing","Implantation of a dual-chamber pacemaker with the ventricular lead placed in the RV septum.\n\nAt follow-up, the ventricular pacing percentage and pacing configuration will be noted.\n\nAll devices used in this study are commercially available in the European Union and carry a valid CE mark.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Left Bundle Branch Pacing","Implantation of a dual-chamber pacemaker with the ventricular lead placed at the left bundle branch area.\n\nPhysiological pacing will be programmed into the devices and, at follow-up, the percentage of spontaneous pacing will be noted.\n\nAll devices used in this study are commercially available in the European Union and carry a valid CE mark.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"GEORGIOS LEVENTOPOULOS","CONTACT","+306977786020","levent2669@gmail.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Periklis Davlouros","+306986726300","pdav@upatras.gr",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University General Hospital of Patras","RECRUITING","Pátrai","Greece","GR",{"type":48,"coordinates":49},"Point",[50,51],21.73508,38.2462,{"lat":51,"lon":50},[54],{"name":55,"role":33,"phone":34,"phoneExt":25,"email":35},"Georgios Leventopoulos",{"type":57,"investigatorFullName":55,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Assistant Professor of Cardiology - Electrophysiology Patras University Hospital, Greece","100612203","left-bundle-branch-pacing-vs-right-ventricular-pacing-on-ahre-burden-in-patients-with-preserved-lvef-100612203",false,"NCT07250529","Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF","Comparison of Left Bundle Branch Pacing Versus Conventional Right Ventricular Pacing on AHRE Burden in Patients With Preserved Left Ventricular Ejection Fraction and High Ventricular Pacing Dependency (LBBP-AHRE Trial): A Randomized Study","LBBP-AHRE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled implantation of a dual-chamber pacemaker for:\n\nPermanent complete heart block Permanent second-degree AV block (Mobitz II or Mobitz I)\n\n* Documented preserved LVEF (≥50%)\n* Sinus rhythm at baseline\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* History of paroxysmal, persistent, or permanent atrial fibrillation\n* Previous atrial fibrillation ablation (catheter-based or surgical)\n* LVEF \\\u003C 50%\n* Sinus node disease\n* Transient AV block requiring pacemaker implantation\n* Significant structural or valvular heart disease\n* Requirement for pacemaker system upgrade during the study period\n* Requirement for antiarrhythmic therapy for causes other than atrial fibrillation\n* Existing pacemaker or other cardiac device requiring modification for study participation\n* Enrollment in another clinical trial that could interfere with study endpoints or pacing parameters\n* Contraindication to LBBP or associated lead implantation procedure\n* Life expectancy \\\u003C 12 months\n* Any condition judged by the investigator to compromise participation or the integrity of study data","ALL","18 Years",{"count":70,"type":71},244,"ESTIMATED","INTERVENTIONAL",[74],"NA","This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate episodes (AHREs) in patients with preserved left ventricular ejection fraction (LVEF) who are expected to require frequent ventricular pacing.\n\nAtrial High-Rate Episodes (AHREs) are defined as episodes of atrial tachyarrhythmia that are automatically recorded by device diagnostics and detected by implanted cardiac devices. These episodes usually have an atrial rate ≥170 beats per minute and a duration ≥6 minutes. AHREs are linked to a higher risk of thromboembolic events and clinical atrial fibrillation (AF), and they may indicate subclinical AF or other atrial tachyarrhythmias.\n\nChronic RV pacing has been linked to mechanical and electrical dyssynchrony, which may encourage atrial remodeling and the development of AF. LBBP provides a more physiological ventricular activation and may reduce atrial tachyarrhythmia time (AHRE time).\n\nPatients with LVEF \\>50% and atrioventricular (AV) conduction disorders requiring a dual-chamber pacemaker will be randomized to either conventional RV septal pacing or LBBP.",[77,78,79,80],"Atrial Fibrillation (AF)","Pacemaker Therapy","Atrioventricular Block","Preserved Ejection Fraction",[82,83,84,85,86,87,88,89],"Left bundle branch pacing","Cardiac electrophysiology","Right ventricular pacing","AHRE burden","Preserved ejection fraction","Heart Failure","Quality of life","Pacing-induced cardiomyopathy (PICM)","2026-03-10",{"date":92,"type":93},"2026-03-13","ACTUAL",{"date":95,"type":93},"2026-02-05",{"date":97,"type":71},"2029-06-20",{"name":5,"class":6},1]