Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Older than 18 years. 2. Diagnosed with drug-refractory, symptomatic atrial fibrillation. 3. The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2). 4. Have a situation of: 1. requires oral anticoagulation therapy 2. high bleeding risk (HAS-BLED score ≥ 3) that unsuitable for or unwilling to undergo long-term oral anticoagulation therapy. 5. Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program. Exclusion Criteria: 1. History of persistent atrial fibrillation \>1 year. 2. Atrial fibrillation was secondary to thyroid disease or other reversible reasons. 3. Left atrial anteroposterior diameter \>50 mm. 4. Evidence of left atrial or left atrial appendage thrombus on imaging examination. 5. Concurrent other arrhythmias required for catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventr