None listed
Conditions
Interventions
Others : 1) Eligible participants who meet the inclusion and exclusion criteria will undergo Bachmann bundle pacing.
If Bachmann bundle pacing is successfully achieved, participants will be randomly
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age =18 years at the time of screening. 2) A documented diagnosis of chronic heart failure with New York Heart Association (NYHA) class II–IV. 3) Left ventricular ejection fraction (LVEF) =40%, documented by an imaging study performed within 12 months prior to screening. 4) Receiving optimized guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF), unless contraindicated or not tolerated: *Participants receiving ongoing treatment must be on a stable regimen for at least 1 month prior to screening (except for diuretics). *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. 5) Presence of interatrial block (IAB), defined as a P-wave duration =120 ms on a 12-lead electrocardiogram or ECG recording device. 6) An indication for dual-chamber implantable cardioverter-defibrillator (ICD) implantation for primary or secondary prevention. 7) NT-proBNP measured within 3 months prior to randomization meeting one of the following criteria * NT-proBNP >300 pg/mL
Exclusion criteria
Exclusion criteria: 1) Non-paroxysmal AF. 2) Uncontrolled tachyarrhythmia. 3) Sinus bradycardia requiring continuous atrial pacing or atrioventricular block requiring ventricular pacing. 4) Acute decompensated heart failure at the time of screening or hospitalization for worsening heart failure within 4 weeks prior to enrollment. 5) Moderate to severe primary valvular heart disease(functional mitral regurgitation or tricuspid regurgitation is not an exclusion criterion). 6) Prior mechanical tricuspid valve replacement. 7) Coronary revascularization (PCI or CABG) or valve surgery/repair performed within 12 weeks prior to enrollment, or planned after randomization. 8) Obstructive hypertrophic cardiomyopathy. 9) Infiltrative cardiomyopathy, including but not limited to amyloidosis, sarcoidosis, or Fabry disease. 10) An indication for cardiac resynchronization therapy (CRT). 11) Chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) 3 times the upper limit of normal at screening. 13) Severe pulmonary disease, such as cor pulmonale or irreversible lung disease requiring inhaled therapy or long-term oxygen therapy. 14) Uncontrolled hypertension, defined as a mean blood pressure >140/90 mmHg based on outpatient clinic measurements or home blood pressure recordings within the previous 30 days, or ongoing up-titration of antihypertensive medications. 15) Pregnant or breastfeeding women, or women planning pregnancy or breastfeeding during the study period. 16) Active malignancy requiring treatment at the time of screening. 17) Life expectancy <12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in NT-proBNP at 6 weeks (accelerated Bachmann bundle area pacing ON) compared with baseline (accelerated Bachmann bundle area pacing OFF). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 6 weeks, 16 weeks, and 12 months compared with baseline.;Change in diastolic function parameters at 6 weeks, 16 weeks, and 12 months compared with baseline, including E wave velocity, A wave velocity, E/A ratio, and E/E' ratio.;Change in left atrial parameters at 6 weeks, 16 weeks, and 12 months compared with baseline, including left atrial diameter, left atrial strain, and left atrial volume index (LAVI). ;Change in left ventricular ejection fraction (LVEF) at 6 weeks, 16 weeks, and 12 months compared with baseline. ;Change in NYHA functional class at 6 weeks, 16 weeks, and 12 months.;Change in peak oxygen consumption (VO2 max) at 6 weeks, 16 weeks, and 12 months compared with baseline.;Incidence of newly detected atrial fibrillation (AF).;Atrial fibrillation (AF) burden. ;Change in 6-minute walk distance (6MWD) compared with baseline.;Clinical outcomes at 12 months, including: a) All-cause mortality b) Worsening heart failure, regardless of hospitalization* c) Composite outcome of (a) and (b);Assessment of risks related to ICD implantation, including: Pocket hematoma, Infection, Diaphragmatic or phrenic nerve stimulation, Lead-related endocarditis, Lead dysfunction or dislodgement, Pneumothorax, Hemopericardium, Death | — |
Countries
Korea, Republic of
Contacts
Public ContactDo-Hee Kim
Seoul National University Hospital
Outcome results
None listed