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

NCT07783984 | Recruiting

• 2 other identifiers: SMC 2023-06-103KCT0009360
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Thoracoscopic Ablation; Endocardial Ablation

Outcome Measures

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.

  From 3 months after the index procedure until 1 year after enrollment of the last patient

Secondary Outcomes (8)

• Recurrence of atrial fibrillation

  From 3 months after the index procedure until 1 year after enrollment of the last patient

• Recurrence of atrial flutter

  From 3 months after the index procedure until 1 year after enrollment of the last patient

• Recurrence of atrial tachycardia

  From 3 months after the index procedure until 1 year after enrollment of the last patient

• All-cause death

  From 3 months after the index procedure until 1 year after enrollment of the last patient

• Cardiac death

  From 3 months after the index procedure until 1 year after enrollment of the last patient

Study Arms (2)

Thoracoscopic ablation

EXPERIMENTAL

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.

Procedure: Thoracoscopic ablation

Percutaneous catheter ablation

ACTIVE COMPARATOR

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.

Procedure: Percutaneous catheter ablation

Interventions

Thoracoscopic ablation PROCEDURE

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.

Thoracoscopic ablation

Percutaneous catheter ablation PROCEDURE

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.

Percutaneous catheter ablation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Young Keun On, MD, PhD

CONTACT

+82-2-3410-2578; yk.on@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 25, 2026
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)