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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
292
abc
bcd
Ningbo First Hospital
Hangzhou, China
RECRUITING12-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)
Time frame: 12 months post-procedure
Acute pulmonary vein ablation success rate
Defined as maintained bidirectional block across the ablation line 20 minutes after ablation
Time frame: Immediately post-procedure
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
Time frame: Within 7 days post-procedure
Incidence of repeat ablation
Summary ncidence of repeat ablation after the blanking period
Time frame: Within 12 months post-procedure
AF burden
Record AF burden at 6 and 12 months post-procedure
Time frame: 6 and 12 months post-procedure
Incidence of cardiovascular MAEs
Incidence of thromboembolic events (including stroke/TIA), cardiovascular-related rehospitalization, or cardiovascular mortality within 12 months post-procedure
Time frame: Within 12 months post-procedure
Technical success rate of LAAC
Defined as successful LAA occlusion without residual shunt \>3 mm and no device-related complications
Time frame: Immediately post-procedure
LAA closure rate
Defined as imaging-confirmed residual shunt ≤3 mm at the device edges.
Time frame: 3 and 6 months post-procedure
Incidence of new residual shunt
Defined as any increase in residual shunt (post-procedure shunt volume - intraoperative shunt volume \>0 mm)
Time frame: 3 and 6 months post-procedure
Incidence of device-related thrombus
Record device-related thrombus events during follow-up
Time frame: Within 12 months post-procedure.
Discontinuation rate of anticoagulants and antiarrhythmic medications
Record drugs history during follow up
Time frame: Within 12 months post-procedure
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