400
Participants
Start Date
October 23, 2023
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2026
Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation
"In addition to standard touch-up of pulmonary vein isolation, subjects receive targeted 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-identified sources with activity above the threshold (≥ 25%) are considered significant and targeted with radiofrequency ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold."
Electrographic Flow (EGF) mapping (no ablation)
"In addition to standard pulmonary vein isolation (PVI), subjects receive Electrographic Flow™ (EGF) mapping. PVI may be performed using any commercially available platform/catheter.~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-identified sources with activity above the threshold (≥ 25%) are marked as relevant; however, no EGF-guided ablations are performed during this index procedure. If subjects have AF recurrence after the 90-day blanking period, they may undergo a recurrence procedure and EGF-guided ablation."
ZNA Middelheim, Antwerp
ZOL, Genk
OLV Hospital Aalst, Aalst
Mount Sinai Hospital, New York
Inova Health, Falls Church
University of Virginia, Charlottesville
Piedmont Health, Athens
Ascension Medical Group, Jacksonville
Florida Heart Rhythm Specialists, Fort Lauderdale
University of Alabama, Birmingham
Grandview Medical Center, Birmingham
Ohio State University, Columbus
Beaumont Health, Royal Oak
Colorado Heart, Golden
Banner Health, Phoenix
Pacific Heart Institute, Santa Monica
Sutter Health Sequoia Heart and Vascular Institute, Redwood City
Evergreen Health Research/Overlake Medical Center, Bellevue
Neuron Medical, Brno
IKEM (Institute for Clinical and Experimental Medicine), Prague
Na Homolce Hospital, Prague
Amsterdam UMC (location AMC), Amsterdam
St. Antonius Hospital, Nieuwegein
Erasmus MC, Rotterdam
Lead Sponsor
Collaborators (1)
Ablacon, Inc.
INDUSTRY
Cortex
INDUSTRY