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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CardiPulse Group | Experimental | Patients accept atrial fibrillation ablation with CardiPulse pulsed field ablation catheter |
|
| FaraPulse Group | Active Comparator | Patients accept atrial fibrillation ablation with FaraPulse pulsed field ablation catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardiPulse | Device | abc |
| |
| FaraPulse |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute pulmonary vein ablation success rate | Defined as maintained bidirectional block across the ablation line 20 minutes after ablation | Immediately post-procedure |
| Incidence of major adverse events (MAEs) related to the device |
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Inclusion Criteria:
Older than 18 years.
Diagnosed with drug-refractory, symptomatic atrial fibrillation.
The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2).
Have a situation of:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huimin Chu, Dorctor | Contact | +86 574-87085211 | epnbheart@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo First Hospital | Recruiting | Hangzhou | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Device |
bcd |
|
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
| Within 7 days post-procedure |
| Incidence of repeat ablation | Summary ncidence of repeat ablation after the blanking period | Within 12 months post-procedure |
| AF burden | Record AF burden at 6 and 12 months post-procedure | 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 | 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 | Immediately post-procedure |
| LAA closure rate | Defined as imaging-confirmed residual shunt ≤3 mm at the device edges. | 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) | 3 and 6 months post-procedure |
| Incidence of device-related thrombus | Record device-related thrombus events during follow-up | Within 12 months post-procedure. |
| Discontinuation rate of anticoagulants and antiarrhythmic medications | Record drugs history during follow up | Within 12 months post-procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |