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

NACompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

September 27, 2019

Primary Completion Date

September 27, 2021

Study Completion Date

September 27, 2021

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."

Trial Locations (4)

20246

University Heart and Vascular Center Hamburg, Hamburg

150 30

Nemocnice Na Homolce Hospital, Prague

01099

Practice Clinic Heart And Vessels, Dresden

3015GD

Erasmus Medical Center, Rotterdam

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Ablacon, Inc.

INDUSTRY

lead

Cortex

INDUSTRY

NCT04473963 - FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology | Biotech Hunter | Biotech Hunter