This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.
Ablation using PFA. Guided by anatomical landmarks without potential mapping
Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.
No. 241, West Huaihai Road
Shanghai, Shanghai Municipality, China
Freedom from Atrial Arrhythmia Recurrence at 12 Months
Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation.
Time frame: 12 months after ablation procedure
Procedural Safety
Incidence of procedural complications such as esophageal injury and pulmonary vein stenosis.
Time frame: From enrollment to completion of follow-up（at least 12 months）
Symptom Relief and Quality of Life Enhancement.
Improvement in clinical symptoms (EHRA score) and quality of life measurements (Short Form 36 HealthSurvey).
Time frame: From enrollment to completion of follow-up（at least 12 months）
Atrial Fibrillation Burden Reduction
Reduction in atrial fibrillation burden assessed through follow-up evaluations.
Time frame: From enrollment to completion of follow-up（at least 12 months）
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