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

Study results available
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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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05481359 on ClinicalTrials.gov