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FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology

NCT04473963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-04-10

Study results available
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Summary

This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).

Conditions

  • Atrial Fibrillation, Persistent

Interventions

DEVICE

Electrographic Flow™ guided ablation

In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping. 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 software. Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity above the threshold (≥ 26.5%) are considered significant and targeted for ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold.

Sponsors & Collaborators

  • Ablacon, Inc.

    collaborator INDUSTRY

  • Cortex

    lead INDUSTRY

Principal Investigators

  • Petr Neuzil, MD · Principal Investigator - Czech Republic

  • Tamas Szili-Torok, MD · Principal Investigator - The Netherlands

  • Stefan Spitzer, MD · Principal Investigator - Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2021-09-27
Completion
2021-09-27

Countries

  • Czechia
  • Germany
  • Netherlands

Study Locations

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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 NCT04473963 on ClinicalTrials.gov