Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation
Recruiting · NCT06699342 · Interventional (participants receive a specific treatment) · Lead sponsor: Seoul National University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Atrioventricular node ablation (AVNA)Pacemaker implantation with Left bundle branch area pacing (LBBAP)Pharmacologic therapy optimized for Atrial Fibrillation management
What this trial is about
This study aimed to compare the clinical outcomes of left bundle branch area pacing combined with atrioventricular node ablation and pharmacologic treatment optimized according to guidelines in patients with symptomatic atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Permanent atrial fibrillation
- Age ≥ 65 years
- Refractory or intolerant to antiarrhythmic drugs, rate control medications, or catheter ablation
- New York Heart Association (NYHA) functional class II- IV
- LVEF \> 40% (within the past 3 months)
- Patients with at least one of the following:
- HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting ≥12 hours and including treatment with intravenous (IV) diuretics at a healthcare facility) within 12 months
- Elevated NT-proBNP (\>900 pg/ml) in the 30 days prior to enrollment
- Exclusion:
- Patients who meet at least one of the following
Exclusion criteria
- Asymptomatic atrial fibrillation
- Life expectancy to \< 12 months.
- Primary moderate to severe valvular disease (except for functional mitral valve regurgitation or tricuspid valve regurgitation)
- Mechanical tricuspid valve replacement
- Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 15 ml/1,73 m2 or receiving renal replacement treatment including hemodialysis or peritoneal dialysis)
- Obstructive hypertrophic cardiomyopathy
- Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
- Acute coronary syndrome or coronary revascularization (CABG or PCI) \<3 months
- Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation
- Pacemaker/ICD/CRT treatment ongoing, or current pacemaker indication
- Simultaneous participation in a different randomized clinical trial
Where it is running
1 location listed.
- Seoul National University Hospital - Seoul, Jongno-gu, South Korea