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Endocardial Catheter Ablation Versus Thoracoscopic Ablation in De Novo Persistent Atrial Fibrillation Patients With Enlarged Left Atrium: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Young Keun On, MD, PhD
yk.on@samsung.com
+82-2-3410-2578
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 194
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov