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RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.
Sponsor: Cortex
Summary
Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures. Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.
Official title: Prospective, Single Arm, Multi-center, Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-pulmonary Vein Sources of Atrial Fibrillation and Guide Ablation Therapy.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2023-10-23
Completion Date
2026-01
Last Updated
2025-04-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (24)
University of Alabama
Birmingham, Alabama, United States
Grandview Medical Center
Birmingham, Alabama, United States
Banner Health
Phoenix, Arizona, United States
Sutter Health Sequoia Heart and Vascular Institute
Redwood City, California, United States
Pacific Heart Institute
Santa Monica, California, United States
Colorado Heart
Golden, Colorado, United States
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida, United States
Ascension Medical Group
Jacksonville, Florida, United States
Piedmont Health
Athens, Georgia, United States
Beaumont Health
Royal Oak, Michigan, United States
Mount Sinai Hospital
New York, New York, United States
Ohio State University
Columbus, Ohio, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Health
Falls Church, Virginia, United States
Evergreen Health Research/Overlake Medical Center
Bellevue, Washington, United States
OLV Hospital Aalst
Aalst, Belgium
ZNA Middelheim
Antwerp, Belgium
ZOL
Genk, Belgium
Neuron Medical
Brno, Czechia
IKEM (Institute for Clinical and Experimental Medicine)
Prague, Czechia
Na Homolce Hospital
Prague, Czechia
Amsterdam UMC (location AMC)
Amsterdam, North Holland, Netherlands
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Erasmus MC
Rotterdam, Netherlands