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Thoracoscopic Versus Catheter Ablation in Persistent Atrial Fibrillation With Enlarged Left Atrium

RECRUITINGN/ASponsored by Samsung Medical Center
Actively Recruiting
PhaseN/A
SponsorSamsung Medical Center
Started2024-05-01
Est. completion2028-05-01
Eligibility
Age19 Years+
Healthy vol.Accepted

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.

Eligibility

Age: 19 Years+Healthy volunteers accepted
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

Conditions4

Atrial FibrillationEndocardial AblationHeart DiseaseThoracoscopic Ablation

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