Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07807423
NA

Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation.

Sponsor: Volta Medical

View on ClinicalTrials.gov

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

Interventions

DEVICE

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