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Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation.
Sponsor: Volta Medical
Summary
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.
Official title: Relationship Between Spatiotemporal Dispersion Areas DISPLAYed by Volta Medical Artificial Intelligence Software and Atrial Arrhythmia Recurrence After Pulmonary Vein Isolation-Only Ablation for Persistent Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2026-09
Completion Date
2028-02
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
Complete biatrial mapping
All 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
Locations (5)
Clinique Rhône Durance
Avignon, France
Hôpital Cardiologique Louis Pradel - HCL
Bron, France
CHU Dijon
Dijon, France
Hôpital Saint-Joseph Marseille
Marseille, France
Clinique Rhéna
Strasbourg, France