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Thoracoscopic Versus Catheter Ablation in Persistent Atrial Fibrillation With Enlarged Left Atrium
Sponsor: Samsung Medical Center
Summary
This is a prospective, single-center, open-label, randomized controlled trial comparing thoracoscopic surgical ablation with percutaneous endocardial catheter ablation as the first rhythm-control procedure in patients with persistent atrial fibrillation and an enlarged left atrium (LA diameter ≥50 mm or LA volume index ≥45 mL/m²). A total of 194 patients who have never undergone an ablation procedure for atrial fibrillation will be randomly assigned 1:1 to thoracoscopic ablation or percutaneous catheter ablation, stratified by duration of atrial fibrillation. The primary endpoint is recurrence of atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) after a 3-month blanking period. The investigators hypothesize that thoracoscopic ablation will significantly reduce recurrence compared with catheter ablation in this population. A secondary hypothesis is that 14-day patch monitoring detects recurrent atrial tachyarrhythmia more sensitively than conventional 24-hour Holter monitoring.
Official title: Endocardial Catheter Ablation Versus Thoracoscopic Ablation in De Novo Persistent Atrial Fibrillation Patients With Enlarged Left Atrium: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
194
Start Date
2024-05-01
Completion Date
2029-05-01
Last Updated
2026-08-25
Healthy Volunteers
No
Interventions
Thoracoscopic ablation
Thoracoscopic surgical ablation is performed according to the standard technique. Pulmonary vein isolation and left atrial appendage exclusion are mandatory. Additional lesions are at the operator's discretion.
Percutaneous catheter ablation
Percutaneous endocardial catheter ablation is performed using radiofrequency, cryoballoon, or pulsed field energy. Pulmonary vein isolation is mandatory. Additional lesions are at the operator's discretion.
Locations (1)
Samsung Medical Center
Seoul, Seoul, South Korea