[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635024":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":38,"centralContacts":42,"locations":30,"responsibleParty":47,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":30,"enrollmentInfo":63,"targetDuration":30,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":30,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":30},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"BBAP on","EXPERIMENTAL","In the Bachmann bundle pacing ON group, the implantable cardioverter-defibrillator will be programmed for 6 weeks with a lower rate limit (LRL) of 70 beats per minute, DDDR mode, and atrial preference pacing (APP) enabled.\n\nAfter the initial 6-week randomized period, to eliminate the effects of prior pacing, the implantable cardioverter-defibrillator in both groups will be reprogrammed to an LRL of 30 beats per minute in VVI mode, followed by a 4-week washout period.\n\nAfter the washout period, participants will undergo crossover, such that those initially assigned to the Bachmann bundle pacing ON group will be switched to the OFF group, and those initially assigned to the OFF group will be switched to the ON group, with the assigned pacing mode maintained for an additional 6 weeks.",[13],"Device: BBAP on",{"label":15,"type":16,"description":17,"interventionNames":18},"BBAP off","ACTIVE_COMPARATOR","In the Bachmann bundle pacing OFF group, the implantable cardioverter-defibrillator will be programmed for 6 weeks with an LRL of 30 beats per minute in VVI mode.\n\nAfter the initial 6-week randomized period, to eliminate the effects of prior pacing, the implantable cardioverter-defibrillator in both groups will be reprogrammed to an LRL of 30 beats per minute in VVI mode, followed by a 4-week washout period.\n\nAfter the washout period, participants will undergo crossover, such that those initially assigned to the Bachmann bundle pacing ON group will be switched to the OFF group, and those initially assigned to the OFF group will be switched to the ON group, with the assigned pacing mode maintained for an additional 6 weeks.",[19],"Device: BBAP off",{"label":21,"type":6,"description":22,"interventionNames":23},"RAAP on","A comparator cohort receiving accelerated atrial resynchronization via right atrial appendage pacing will be enrolled separately at institutions distinct from those recruiting participants for Bachmann bundle pacing. In the right atrial appendage pacing cohort, the implantable cardioverter-defibrillator will be programmed for the initial 6 weeks with an LRL of 70 beats per minute, DDDR mode, and atrial preference pacing enabled. Individualized adjustment of the LRL will be permitted at the investigator's discretion based on the patient's clinical status.",[24],"Drug: RAAP",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","ICD programmed for 6 weeks with LRL 70 beats\u002Fmin, DDDR, and APP enabled.",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"ICD programmed for 6 weeks with an LRL 30 beats\u002Fmin in VVI mode",[15],{"type":35,"name":36,"description":28,"armGroupLabels":37,"otherNames":30},"DRUG","RAAP",[21],[39],{"name":40,"affiliation":5,"role":41},"Eue-Keun Choi, M.D. Ph.D.","PRINCIPAL_INVESTIGATOR",[43],{"name":40,"role":44,"phone":45,"phoneExt":30,"email":46},"CONTACT","82-2-2072-0688","choiek417@gmail.com",{"type":41,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Eue-Keun Choi","Professor",[51],{"name":52,"class":53},"Medtronic","INDUSTRY","100635024","evaluation-of-accelerated-bachmann-bundle-area-pacing-in-heart-failure-with-reduced-ejection-fraction-who-have-electrocardiographic-evidence-of-interatrial-block-and-indicated-for-implantable-cardioverter-defibrillator-100635024",false,"NCT07547306","Evaluation of Accelerated Bachmann Bundle Area Pacing in Heart Failure With Reduced ejectIon Fraction Who Have electrocarDioGraphic Evidence of Interatrial Block and Indicated for Implantable Cardioverter Defibrillator","BRIDGE-HF","Inclusion Criteria:\n\n1. Age ≥18 years at the time of screening.\n2. A documented diagnosis of chronic heart failure with New York Heart Association (NYHA) class II-IV.\n3. Left ventricular ejection fraction (LVEF) ≤40%, documented by an imaging study performed within 12 months prior to screening.\n4. Receiving optimized guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF), unless contraindicated or not tolerated:\n\n   * Participants receiving ongoing treatment must be on a stable regimen for at least 1 month prior to screening (except for diuretics).\n   * Most patients with heart failure require diuretics for volume control, and dose adjustments may be made based on clinical status, including symptoms, signs, and body weight. Each participant should receive individualized diuretic therapy to maintain optimal volume status.\n5. Presence of interatrial block (IAB), defined as a P-wave duration ≥120 ms on a 12-lead electrocardiogram or ECG recording device.\n6. An indication for dual-chamber implantable cardioverter-defibrillator (ICD) implantation for primary or secondary prevention.\n7. NT-proBNP measured within 3 months prior to randomization meeting one of the following criteria:\n\n   * NT-proBNP \\>300 pg\u002FmL\n\nExclusion Criteria:\n\n1. Non-paroxysmal AF.\n2. Uncontrolled tachyarrhythmia.\n3. Sinus bradycardia requiring continuous atrial pacing or atrioventricular block requiring ventricular pacing.\n4. Acute decompensated heart failure at the time of screening or hospitalization for worsening heart failure within 4 weeks prior to enrollment.\n5. Moderate to severe primary valvular heart disease (functional mitral regurgitation or tricuspid regurgitation is not an exclusion criterion).\n6. Prior mechanical tricuspid valve replacement.\n7. Coronary revascularization (PCI or CABG) or valve surgery\u002Frepair performed within 12 weeks prior to enrollment, or planned after randomization.\n8. Obstructive hypertrophic cardiomyopathy.\n9. Infiltrative cardiomyopathy, including but not limited to amyloidosis, sarcoidosis, or Fabry disease.\n10. An indication for cardiac resynchronization therapy (CRT).\n11. Chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m² calculated using the CKD-EPI equation.\n12. Chronic liver disease, defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase \\>3 times the upper limit of normal at screening.\n13. Severe pulmonary disease, such as cor pulmonale or irreversible lung disease requiring inhaled therapy or long-term oxygen therapy.\n14. Uncontrolled hypertension, defined as a mean blood pressure \\>140\u002F90 mmHg based on outpatient clinic measurements or home blood pressure recordings within the previous 30 days, or ongoing up-titration of antihypertensive medications.\n15. Pregnant or breastfeeding women, or women planning pregnancy or breastfeeding during the study period.\n16. Active malignancy requiring treatment at the time of screening.\n17. Life expectancy \\\u003C12 months.","ALL","18 Years",{"count":64,"type":65},120,"ESTIMATED","INTERVENTIONAL",[68],"NA","To evaluate the effect of accelerated atrial resynchronization achieved through Bachmann bundle pacing at the time of implantable cardioverter-defibrillator implantation in patients with heart failure with reduced ejection fraction and interatrial block",[71],"Heart Failure and Reduced Ejection Fraction",[73,74,75],"heart failure and reduced ejection fraction","Bachmann bundle area pacing","interatrial block","NOT_YET_RECRUITING","2026-04-20",{"date":79,"type":80},"2026-04-23","ACTUAL",{"date":82,"type":65},"2026-05",{"date":84,"type":65},"2030-12-31",{"name":5,"class":6}]