Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial appendage closure (LAAC) as a one-stop treatment, with few reports of post-ablation tissue edema. However, during PFA procedures, the presence of metallic components in the ablation site (e.g., occluder frames, metallic valves) may lead to arcing during energy delivery, compromising procedural safety. Therefore, when performing PFA+LAAC as a one-stop procedure, a "ablation-first" strategy is recommended. Due to the influence of parameters such as voltage, pulse width, and number of cycles on pulsed field energy characteristics, significant variability in ablation depth and area may exist between different PFA devices. To date, no large-scale clinical studies have compared the efficacy and safety of different PFA systems. Accordingly, this study will conduct a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of domestic versus imported pulsed field ablation catheters in the treatment of patients with atrial fibrillation.
Older than 18 years.
Diagnosed with drug-refractory, symptomatic atrial fibrillation.
The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2).
requires oral anticoagulation therapy
History of persistent atrial fibrillation >1 year.
Atrial fibrillation was secondary to thyroid disease or other reversible reasons.
Left atrial anteroposterior diameter >50 mm.
Evidence of left atrial or left atrial appendage thrombus on imaging examination.
Parallel
CardiPulse
Deviceabc
FaraPulse
Devicebcd
12-month atrial fibrillation (AF) ablation success rate
Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)
Acute pulmonary vein ablation success rate
Defined as maintained bidirectional block across the ablation line 20 minutes after ablation
Incidence of major adverse events (MAEs) related to the device
Including stroke/transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve paralysis, systemic embolism, pericarditis, pericardial effusion/cardiac tamponade, atrioesophageal fistula, myocardial infarction, or severe vascular access complications
Incidence of repeat ablation
Summary ncidence of repeat ablation after the blanking period
AF burden
Record AF burden at 6 and 12 months post-procedure
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