DISPLAY-AF is a prospective, multicenter, single-arm post-market clinical follow-up investigation designed to evaluate whether spatiotemporal dispersion areas identified by the Volta AF-Xplorer II artificial intelligence (AI) software can predict recurrence of atrial arrhythmias after pulmonary vein isolation (PVI)-only ablation in patients with persistent atrial fibrillation.
Patient aged 18 years or older.
De novo patient candidate for catheter ablation of persistent atrial fibrillation (AF episode >7 days).
Continuous anticoagulation for more than 4 weeks before ablation.
Patient giving his signed consent form to participate in the clinical study.
Contraindication to AF/AT catheter ablation.
Major bleeding disorder.
Contraindication to anticoagulation (Heparin, Warfarin or NOAC…) or lack of anticoagulation for 4 weeks prior to the procedure.
Presence of a LA thrombus on transesophageal echocardiography (TEE) prior to the procedure.
Single group
Complete biatrial mapping
DeviceAll enrolled patients undergo catheter ablation for persistent atrial fibrillation. During the mapping phases of the procedure, the CE-marked Volta AF-Xplorer II artificial intelligence software is used according to its intended use to identify and display areas exhibiting spatiotemporal dispersion. Complete biatrial mappings of spatiotemporal dispersion areas are performed before and after Pulmonary Vein Isolation using Volta AF-Xplorer II connected to a compatible electroanatomical 3D mapping system (EnSite or CARTO). For the abation, Pulmonary vein isolation (PVI) is performed using radiofrequency (RF) or pulsed field ablation (PFA), consisting of the creation of contiguous circumferential lesions around each pulmonary vein antrum. The main phases of the ablation procedure are: * 1st complete biatrial mapping * Ablation (PVI only) * 2nd complete biatrial mapping
PVI non-responder rate defined as the proportion of patients experiencing atrial arrhythmia recurrence (documented AF/AT episode ≥30 seconds) within 12 months following a PVI-only ablation procedure according to the extra-PV/Perivenous Dispersion ratio.
PVI non-responder rate per type of atrial arrythmia recurrence within 12 months following a PVI-only ablation procedure according to the extra-PV/Perivenous Dispersion ratio.
PVI non-responder rate within 12 months following a PVI-only ablation procedure according to the dispersion localization.
Volta AF-Xplorer II-related Serious Incident rate.
Spatio-temporal dispersion extent and distribution obtained before and after PVI (LA, RA, biatrial)
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