NCT05481359

AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation

A Post Market, Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using Electrographic Flow (EGF™) Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation in Real-world Setting.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Ablacon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.

Detailed description

The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of Electrographic Flow (EGF™) mapping with Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of EGF mapping to identify sources of atrial fibrillation (AF) and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with AF and meet inclusion/exclusion criteria will be eligible for enrollment.

Conditions

• Atrial Fibrillation, Persistent
• Atrial Fibrillation
• Arrhythmias, Cardiac
• Heart Diseases

Interventions

Type	Name	Description
DEVICE	Electrographic Flow™ (EGF) mapping and ablation	Electrographic Flow™ (EGF) mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF). EGF mapping involves 1 minute recordings of unipolar electrograms from a basket catheter, which are then processed with the EGF algorithm (Ablamap® Software). Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity levels exceeding the recommended threshold are deemed significant and are targeted for ablation. The success of the ablation is confirmed through an EGF remap, where elimination of the source is defined as reduction of EGF source activity below the threshold.

Timeline

• Start date: 2022-09-12
• Primary completion: 2022-10-27
• Completion: 2023-11-17
• First posted: 2022-08-01
• Last updated: 2025-04-10
• Results posted: 2025-04-10

Locations

5 sites across 3 countries: United States, Netherlands, Poland

Regulatory

• FDA-regulated device study