Thoracoscopic Versus Catheter Ablation in Persistent Atrial Fibrillation With Enlarged Left Atrium
Recruiting · NCT07783984 · Interventional (participants receive a specific treatment) · Lead sponsor: Samsung Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age 19 years or older
- Persistent atrial fibrillation refractory to antiarrhythmic drug therapy, or in whom antiarrhythmic drug therapy cannot be maintained
- European Heart Rhythm Association (EHRA) symptom score ≥ 2
- Considered suitable for rhythm-control therapy by either percutaneous catheter ablation or thoracoscopic ablation, at the investigator's medical discretion
- Enlarged left atrium, defined as left atrial diameter ≥ 50 mm or left atrial volume index ≥ 45 mL/m²
Exclusion criteria
- Previous percutaneous catheter ablation or thoracoscopic ablation for atrial fibrillation
- Previous thoracic or cardiac surgery
- Absolute contraindication to anticoagulation therapy
- Life expectancy less than 1 year due to non-cardiac disease, or anticipated poor adherence to treatment, at the investigator's medical discretion
- Refusal to participate in the study
Where it is running
1 location listed.
- Samsung Medical Center - Seoul, Seoul, South Korea