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).
Age >= 18 years.
Symptomatic paroxysmal atrial fibrillation (AF duration < 7 days).
Ineffective treatment with one or more antiarrhythmic drugs (e.g., propafenone, sotalol, amiodarone).
Discontinued antiarrhythmic drugs for at least 5 half-lives before the procedure.
Previous radiofrequency catheter ablation (RFCA) for atrial fibrillation.
Presence of a cardiac pacemaker or post-left atrial appendage closure.
Thrombocytopenia (PLT < 80×10^9/L) or contraindications to anticoagulation (e.g., warfarin, heparin, direct factor Xa inhibitors, direct thrombin inhibitors).
Left atrial anterior-posterior diameter > 55 mm (by transthoracic echocardiography, parasternal long-axis view).
Parallel
Novel Pulsed Field Ablation System
DeviceUse a novel PFA system (YTL-PFA01) and a three-dimensional electroanatomical mapping system to perform pulmonary vein isolation.
Radiofrequency Ablation Catheter
DeviceUse conventional radiofrequency ablation catheters to perform pulmonary vein isolation.
Freedom from atrial arrhythmia recurrence at 12 months
Percentage of participants free from documented atrial arrhythmias (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting \>30 seconds at 12 months post-ablation.
Incidence of major procedure-related complications
Incidence of major adverse events related to the procedure, such as cardiac tamponade, thromboembolic events, vascular complications, pulmonary vein stenosis, and phrenic nerve injury.
Change in left atrial volume index (LAVI)
Change from baseline in left atrial volume index (LAVI) at each follow-up visit.
Change in left ventricular ejection fraction (LVEF)
Change from baseline in left ventricular ejection fraction (LVEF) at each follow-up visit.
Change in mitral inflow E/A ratio
Change from baseline in E/A ratio at each follow-up visit.
Change in left atrial reservoir strain (LASr)
Change from baseline in LASr at each follow-up visit.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
