NCT04945746

Dispersion Stability

Study Evaluating the Prioritization of Ablation Zones According to the Stability of the Dispersion

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Hospital St. Joseph, Marseille, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the acute efficacy of ablation of the most stable VX1 areas (levels 2 and 3) in terms of the rate of acute AF termination. Identify the spatial distribution of dispersion stability levels based on VX1. Document the rate of adverse events. To assess the long-term efficacy of ablation of the most stable VX1 areas in terms of the absence of documented arrhythmias during a 12-month follow-up.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	AF ablation	AF ablation using the Volta Medical VX1 CE marked software and a new criteria to establish a priority of the dispersed zones according to the stability of the core algorithm's response (thanks to the new software module under study named "stability").

Timeline

• Start date: 2021-08-05
• Primary completion: 2023-10-28
• Completion: 2025-01-28
• First posted: 2021-06-30
• Last updated: 2024-09-19

Locations

1 site across 1 country: France