Clinical Research Directory

Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: Clinical Efficacy and Left Atrial Function Protection

Sponsor: Tianjin Medical University General Hospital

Summary

This is a prospective clinical study aiming to evaluate the clinical efficacy and safety of a novel domestic pulsed field ablation (PFA) system in the treatment of paroxysmal atrial fibrillation (PAF), and to specifically assess its protective effect on left atrial function. Approximately 200-220 patients with paroxysmal atrial fibrillation are planned to be enrolled. Participants will be treated with the novel PFA system (YTL-PFA01) and a three-dimensional electroanatomical mapping system. The primary objectives include: Efficacy: Immediate pulmonary vein isolation success rate, and freedom from atrial arrhythmias (\>30 seconds) at 12 months post-procedure. Safety: Incidence of major complications (such as cardiac tamponade, stroke, pulmonary vein stenosis, phrenic nerve palsy). Left Atrial Function: Dynamic changes in echocardiographic parameters (e.g., LAVI, LVEF, E/A, LASr/cd/ct) and serum biomarkers (e.g., troponin, BNP, inflammatory markers) at multiple time points before and after the procedure. Patients will be followed up for 12 months to evaluate the long-term outcomes and quality of life improvement (EQ-5D-5L). The study duration is expected to be 36 months (October 2025 to September 2028).

Official title: Clinical Application Evaluation of a Novel Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation and Its Protective Effect on Left Atrial Function

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