[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635035":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":33,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":33,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":33,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":84,"whyStopped":33,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Fu Wai Hospital, Beijing, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bachmann Bundle Pacing","EXPERIMENTAL","Patients receive atrial lead implantation at the Bachmann bundle region, identified by anatomical localization and intracardiac electrogram. Successful BBP is defined by characteristic ECG changes (positive P wave in I\u002FII\u002FIII\u002FaVF, biphasic\u002Fnegative P wave in V1, narrowed P wave duration) and recording of Bachmann bundle potential. If BBP fails, patients are converted to RAA pacing, with failure reasons documented.",[13],"Procedure: Bachmann Bundle Pacing",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Right Atrial Appendage Pacing","ACTIVE_COMPARATOR","Patients receive conventional atrial lead implantation in the right atrial appendage (RAA), the standard clinical atrial pacing method. Intraoperative pacing parameters (threshold, sensing, impedance) are monitored identically to the experimental group to ensure normal pacing function. All patients continue guideline-directed medical therapy for heart failure throughout the study.",[19],"Procedure: Right Atrial Appendage Pacing",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","A minimally invasive endocardial pacing procedure where an atrial lead is placed at the Bachmann bundle region (located at the junction of the right atrium and left atrial appendage) under fluoroscopic and intracardiac electrogram guidance. Successful implantation is confirmed by characteristic ECG changes (positive P wave in leads I\u002FII\u002FIII\u002FaVF, biphasic\u002Fnegative P wave in V1, P wave duration reduction \\>10 ms in patients with interatrial block) and recording of the Bachmann bundle potential.",[9],[26],"BBP",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Right Atrial Appendage Pacing","The standard clinical atrial pacing procedure where an atrial lead is implanted in the right atrial appendage via transvenous access, guided by fluoroscopy. Pacing parameters (threshold, sensing, impedance) are optimized intraoperatively to ensure stable atrial capture, consistent with current clinical practice guidelines for cardiac pacing in heart failure patients.",[15],[32],"RAA Pacing",null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Xiaohan Fan, MD, PhD","CONTACT","+8615611980322","fanxiaohan@fuwaihospital.org",[41],{"facility":42,"status":33,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":33},"Fuwai Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences","Beijing","Beijing Municipality","100037","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Xiaohan Fan","Chief Physician","100635035","bachmann-bundle-pacing-for-prevention-of-new-onset-atrial-fibrillation-in-patients-with-heart-failure-100635035",false,"NCT07547449","Bachmann Bundle Pacing for Prevention of New-Onset Atrial Fibrillation in Patients With Heart Failure","Clinical Efficacy of Bachmann Bundle Pacing on New-Onset Atrial Fibrillation in Patients With Cardiac Insufficiency","Inclusion Criteria:\n\n1. Aged between 18 and 70 years old;\n2. Diagnosis of chronic cardiac insufficiency according to current guidelines, and received guideline-directed medical therapy (GDMT) for at least 3 months;\n3. Have indications for CRT\u002FLBBP or ICD implantation, and expected atrial pacing ratio \\> 20%, including: Sinus rhythm, QRS duration \\> 120ms, LBBB, LVEF ≤ 35% with symptomatic heart failure; Sinus rhythm, QRS duration ≥ 150ms, non-LBBB, LVEF ≤ 35% with symptomatic heart failure; Sinus rhythm, QRS duration \\> 120ms, LBBB, LVEF 36%-50% with symptomatic heart failure; Symptomatic heart failure with LVEF ≤ 50% and expected ventricular pacing ratio \\> 20%; Symptomatic heart failure with LVEF ≤ 50% requiring ICD implantation for primary or secondary sudden death prevention, with atrial pacing indication due to sinus bradycardia or expected atrial pacing ratio \\> 20%;\n4. Patients with pacing-induced cardiomyopathy requiring upgrade therapy, in sinus rhythm, and requiring reimplantation of atrial lead;\n5. Signed written informed consent form approved by the ethics committee.\n\nExclusion Criteria:\n\n1. Expected survival time less than 12 months;\n2. Status after mechanical tricuspid valve replacement, or congenital heart disease (including dextrocardia, transposition of great arteries, single left persistent superior vena cava);\n3. Previous history of atrial fibrillation;\n4. Previous cardiac surgery, or requiring surgical treatment for severe structural heart disease within 1 year;\n5. Pregnancy, planned pregnancy, or heart transplantation;\n6. Patient refusal to participate in the study.","ALL","18 Years","70 Years",{"count":69,"type":70},140,"ESTIMATED","INTERVENTIONAL",[73],"NA","This is a multi-center, prospective, single-blind, randomized controlled clinical trial to evaluate the efficacy and safety of Bachmann bundle pacing (BBP) in preventing new-onset atrial fibrillation (AF) in patients with chronic cardiac insufficiency who have indications for cardiac resynchronization therapy with left bundle branch pacing (CRT\u002FLBBP) or implantable cardioverter defibrillator (ICD) implantation.\n\nA total of 110 eligible patients will be randomly assigned 1:1 to the BBP group or the traditional right atrial appendage (RAA) pacing group. All patients will receive guideline-directed medical therapy (GDMT) for at least 3 months and standardized follow-up for 12 months after device implantation. The primary endpoint is the incidence of new-onset AF within 12 months after implantation. Secondary endpoints include time to first new-onset AF, procedural success rate, changes in cardiac function parameters, and incidence of adverse events. This study aims to provide high-level evidence-based medical evidence for BBP as a new atrial pacing strategy to prevent AF in heart failure patients.",[76,77,78],"Heart Failure","Atrial Fibrillation (AF)","Cardiac Insufficiency",[9,28,80,81,82,83],"Cardiac Resynchronization Therapy","Implantable Cardioverter Defibrillator","Physiological Pacing","New-Onset Atrial Fibrillation","NOT_YET_RECRUITING","2026-04-16",{"date":87,"type":88},"2026-04-23","ACTUAL",{"date":90,"type":70},"2026-04",{"date":92,"type":70},"2028-04",{"name":5,"class":6},1]