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

NCT06699342 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)

Interventions

PROCEDURE

Pacemaker 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.

PROCEDURE

Atrioventricular 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.

DRUG

Pharmacologic 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.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06699342 on ClinicalTrials.gov