Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
A Prospective, Multicenter, Randomized, and Controlled Study of Pulsed Field Ablation System
This study is a mulitcentre, randomized, parallel-group evaluation of pulse field ablation(PFA) and radiofrequency ablation(RFA) in patients being treated for symptomatic paroxysmal AF. Pulmonary-vein isolation (PVI) is the primary intention of catheter ablation in both groups.
Patients are randomized to either pulse field ablation(PFA) using the PFA catheters(Insight Medtech) or radiofrequency ablation(RFA) using the RFA catheters（Biosense Webster).During the ablation procedure, the (1:1) randomly selected ablation modality is used in the left atriuablation procedurem to electrically isolate the pulmonary veins (PVs).All investigators demonstrates the success of PVI by the abolition of conduction of atrial impulses into the PVs. Additional LA linear lesions or complex fractionated atrial electrogram ablation(s) are not allowed, and adenosine testing not performed, in either group. Concomitant ablation of previously documented avotricuspid isthmus-dependent atrial flutter (AFL) is allowed at the ablation procedure in both groups. The acute procedural end point is defined as the absence or dissociation of all PV potentials, as confirmed by bi-directional block using a circular mapping catheter after a 20 min waiting period (subsequent to the last ablation). Randomized groups are held throughout the trial, and re-ablation during the 3-month blanking period is allowed if the re-ablation is performing with the same type of catheter used at the ablation procedure. During the 3-month blanking period, antiarrhythmic drug (AAD) administration is allowed, but amiodarone iscontinuation is required at the time of the ablation procedure. Beta-adrenergic blockers is permitted and can be used at any time during this trail. The primary efficacy endpoint is the 12-month treatment success rate，defining as the use of no class I or III AAD and no AF/AFL/AT episodes between the time of ablation blank (within 3 months after the ablation procedure) and 12 months of follow-up. (Confirmed by a definite ECG or dynamic ECG). ;
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