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)
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to PVI outperforms PVI alone using PFA in maintaining sinus rhythm for PerAF. Enrolled subjects will be randomized by the ratio of 1:1 into PVI and linear ablation arm or PVI alone arm. Subjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device and EIVOM could be performed additionally before or after PFA at the operator's discretion, it is recommended to perform EIVOM first. Subjects randomized to the PVI alone arm will undergo PVI only. If atrial fibrillation (AF) cannot be terminated during ablation, cardioversion will be performed. After ablation, all the subjects will be followed at discharge, 1 month and then at 3-month intervals up to 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
640
Linear 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.
Undergo PVI with the study device
Beijing Anzhen Hospital, affiliated to Capital Medical University
Beijing, China
RECRUITINGPrimary Effectiveness Endpoint with Treatment Success.
Number of Participants free from Arrhythmia, Re-ablation, Cardioversion, and AAD use.
Time frame: Completion of treatment 360 days compared with the baseline
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).
Time frame: Completion of treatment 360 days compared with the baseline
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.
Time frame: Completion of treatment 360 days compared with the baseline.
Secondary Safety Endpoint with Non-SAE.
Number of Participants with Non-Serious Composite Adverse Event
Time frame: Completion of treatment 360 days compared with the baseline
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