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Clinical Trials in South Korea / NCT07783984
Recruiting Not applicable

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

NCT07783984 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Not applicable
Started
2024-05-01
Last updated
2026-08-25

Condition(s) studied

Atrial FibrillationThoracoscopic AblationEndocardial Ablation

Investigational drug(s) / intervention(s)

Thoracoscopic ablationPercutaneous catheter ablation

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.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Recurrence of atrial tachyarrhythmia — From 3 months after the index procedure until 1 year after enrollment of the last patient
    Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia, defined as an episode documented on 12-lead ECG or sustained for at least 30 seconds on continuous monitoring (14-day patch monitor or 24-hour Holter). Recurrences during the 3-month blanking period are not counted as events.

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul Seoul Recruiting

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Other trials for the same condition

Thickness Map-Guided vs. Empirical PV Isolation Using Pulsed Field Ablation for Paroxysmal AF Starting soon
The Evaluation for Prognostic Factors After Catheter Ablation of Atrial Fibrillation: Cohort Study Recruiting
Evaluation of a Single-lead ECG Patch-based Telemetry System for In-hospital Monitoring Starting soon
PULSED AF Post-Approval Study Recruiting
To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07783984 on ClinicalTrials.gov ↗ ← All trials in South Korea