AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation
NCT05481359 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25
Last updated 2025-04-10
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.
Conditions
- Atrial Fibrillation, Persistent
- Atrial Fibrillation
- Arrhythmias, Cardiac
- Heart Diseases
Interventions
- 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.
Sponsors & Collaborators
-
Cortex
collaborator INDUSTRY -
Ablacon, Inc.
lead INDUSTRY
Principal Investigators
-
Kent Nilsson, MD · Piedmont Athens Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-12
- Primary Completion
- 2022-10-27
- Completion
- 2023-11-17
- FDA Device
- Yes
Countries
- United States
- Netherlands
- Poland
Study Locations
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