Atrial Fibrillation (AF)
Conditions
Keywords
atrial fibrillation, pulsed field ablation, LAAC
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.
Interventions
DEVICECardiPulse
abc
DEVICEFaraPulse
bcd
Sponsors
Hangzhou Dinova EP Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
118 Years to No maximum
Healthy volunteers
No
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, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) prior to enrollment. 6. Rheumatic heart disease. 7. Left ventricular ejection fraction \<40% or New York Heart Association (NYHA) class III/IV. 8. Unstable angina. 9. Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment. 10. History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery. 11. Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings. 12. Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation. 13. Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding. 14. Active systemic infection. 15. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² or history of renal dialysis. 16. Pregnancy or breastfeeding. 17. Life expectancy \<12 months (e.g., advanced malignancy). 18. Current or anticipated participation in other drug or device clinical trials. 19. Any other condition or abnormality deemed by the investigator to warrant exclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month atrial fibrillation (AF) ablation success rate | 12 months post-procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse events (MAEs) related to the device | Within 7 days post-procedure | 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 | Within 12 months post-procedure | Summary ncidence of repeat ablation after the blanking period |
| AF burden | 6 and 12 months post-procedure | Record AF burden at 6 and 12 months post-procedure |
| Incidence of cardiovascular MAEs | Within 12 months post-procedure | Incidence of thromboembolic events (including stroke/TIA), cardiovascular-related rehospitalization, or cardiovascular mortality within 12 months post-procedure |
| Acute pulmonary vein ablation success rate | Immediately post-procedure | Defined as maintained bidirectional block across the ablation line 20 minutes after ablation |
| LAA closure rate | 3 and 6 months post-procedure | Defined as imaging-confirmed residual shunt ≤3 mm at the device edges. |
| Incidence of new residual shunt | 3 and 6 months post-procedure | Defined as any increase in residual shunt (post-procedure shunt volume - intraoperative shunt volume \>0 mm) |
| Incidence of device-related thrombus | Within 12 months post-procedure. | Record device-related thrombus events during follow-up |
| Discontinuation rate of anticoagulants and antiarrhythmic medications | Within 12 months post-procedure | Record drugs history during follow up |
| Technical success rate of LAAC | Immediately post-procedure | Defined as successful LAA occlusion without residual shunt \>3 mm and no device-related complications |
Countries
China
Contacts
Primary ContactHuimin Chu, Dorctor
Outcome results
None listed