Comparing Pulsed Field Ablation and Radiofrequency Ablation Using 3D Imaging for Repeat Treatment of Atrial Fibrillation

What this Trial Is About

Researchers are evaluating two methods for repeat catheter ablation in patients with recurrent atrial fibrillation AF thermal energy ablation using radiofrequency RF and non-thermal electroporation called pulsed field ablation PFA. This randomized clinical trial compares the safety and effectiveness of these two techniques, both guided by 3D imaging systems. The study focuses on patients who have experienced AF recurrence after prior pulmonary vein isolation treatment and require repeat ablation. Participants will be randomly assigned to receive either RF ablation or PFA. Both procedures involve high-resolution electroanatomical mapping of the left atrium to identify targets for ablation. After the energy delivery with the assigned technique, remapping is done to confirm success. No additional invasive procedures are required beyond the standard ablation. Follow-up visits are scheduled at 3, 6, and 12 months with medical history review, physical examination, 12-lead ECG, and 24-hour Holter monitoring. Extra ECG assessments are available if symptoms appear. During the study, participants will be closely monitored through routine clinical assessments and heart rhythm recordings. Data collected includes procedural details, heart anatomy, complications, and arrhythmia recurrence. Safety is monitored through adverse event tracking up to 90 days post-procedure. The main outcome is freedom from atrial arrhythmia over 12 months. The trial lasts up to one year of observation with structured follow-up visits to support early detection and management of any arrhythmias.

Electroporation vs. Radiofrequency Ablation Guided by 3D Imaging in Repeat Procedures for Atrial Fibrillation