This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)
Subjects with an age range of 18 years or above and 80 years or below.
Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath.
Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD.
Persistent: continuous AF for > 90 days, i) with a minimum a physician's note confirming the diagnosis AND,within 180 days of Enrollment Date, either a 24-hour or longer continuous ECG recording confirming continuous AF OR Two ECGs showing continuous AF taken at least 90 days apart.
AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
Left atrial anteroposterior diameter ≥ 6.0 cm by transthoracic echocardiography (TTE) within 3 months prior the procedure.
Heart failure with left ventricular ejection fraction (LVEF) < 30% by TTE within 3 months prior the procedure.
LA thrombus detected by Transesophageal Echocardiography (TEE) or cardiac CT within one day before the procedure or Intracardiac Echocardiography (ICE) before atrial septal puncture during the procedure.
Parallel
Linear ablation
Procedure/SurgeryLinear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device.EIVOM could be performed additionally before or after PFA at the operator's discretion.
PVI alone
Procedure/SurgeryUndergo PVI with the study device
Primary Effectiveness Endpoint with Treatment Success.
Number of Participants free from Arrhythmia, Re-ablation, Cardioversion, and AAD use.
Primary Safety Endpoint with Safety events related to AF catheter ablation.
Number of Participants with following device or procedure-related serious Composite Adverse Events (CAEs).
Secondary Effectiveness Endpoint with Chronic Success.
Number of Participants with Chronic Success, Freedom from any documented AF, AFL or AT episode lasting ≥10s via 12-lead ECG or ≥30s via Holter (or other continuous rhythm monitoring device) on/off AADs after the blanking period to Day 360.
Secondary Safety Endpoint with Non-SAE.
Number of Participants with Non-Serious Composite Adverse Event
Click on the lead sponsor to view all of their trials.
