Thoracoscopic Versus Catheter Ablation in Persistent Atrial Fibrillation With Enlarged Left Atrium
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Thoracoscopic ablation
Procedure/SurgeryThoracoscopic 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
Procedure/SurgeryPercutaneous 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.
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: Thoracoscopic ablationExperimental treatment 1 intervention
Group B: Percutaneous catheter ablationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence of atrial tachyarrhythmia
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.
Time frame
From 3 months after the index procedure until 1 year after enrollment of the last patientSecondary outcomes
1
Recurrence of atrial fibrillation
Time frame
From 3 months after the index procedure until 1 year after enrollment of the last patient2
Recurrence of atrial flutter
Time frame
From 3 months after the index procedure until 1 year after enrollment of the last patient3
Recurrence of atrial tachycardia
Time frame
From 3 months after the index procedure until 1 year after enrollment of the last patient4
All-cause death
Time frame
From 3 months after the index procedure until 1 year after enrollment of the last patientSponsors and contacts
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Source ClinicalTrials.gov