RecruitingNot ApplicableNCT06699342

Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation

Sponsor

Seoul National University Hospital

Enrollment

50 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)

Summary

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.

Eligibility

Min Age: 65 Years

Inclusion Criteria8

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 Criteria11

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

Interventions

PROCEDUREPacemaker implantation with Left bundle branch area pacing (LBBAP)

Left bundle branch pacing is a novel pacing modality that can bypass the pathological or disease-vulnerable region in the cardiac conduction system, to provide physiological pacing modality for patients. The procedure involves the implantation of a permanent pacemaker with a pacing lead positioned at the left bundle branch area to achieve physiological conduction system pacing. LBBAP-Pacemaker device and leads should be implanted according to the physician's standard practice.

PROCEDUREAtrioventricular node ablation (AVNA)

Atrioventricular node ablation uses heat energy, called radiofrequency energy, to destroy the area between the upper and lower heart chambers. This area is called the atrioventricular node.

DRUGPharmacologic therapy optimized for Atrial Fibrillation management

Pharmacologic therapy includes rate control with beta-blockers (e.g., bisoprolol), calcium channel blockers (e.g., diltiazem), or antiarrhythmic drugs (e.g., flecainide, propafenone, dronedarone, amiodarone) along with anticoagulation therapy (e.g., apixaban) as per current clinical guidelines (e.g., ESC 2024 or ACC/AHA/HRS 2023) in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation. Treatment is tailored based on patient tolerance and clinical efficacy.