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.

NAActive, not recruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

October 23, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Atrial FibrillationAtrial Fibrillation, PersistentAtrial Fibrillation ParoxysmalArrhythmiaArrhythmias, CardiacAtrial FlutterAtrial Fibrillation, Paroxysmal or PersistentAtrial ArrhythmiaAtrial Tachycardia
Interventions
DEVICE

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."

DEVICE

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."

Trial Locations (24)

2020

ZNA Middelheim, Antwerp

3600

ZOL, Genk

9300

OLV Hospital Aalst, Aalst

10029

Mount Sinai Hospital, New York

22042

Inova Health, Falls Church

22908

University of Virginia, Charlottesville

30606

Piedmont Health, Athens

32204

Ascension Medical Group, Jacksonville

33308

Florida Heart Rhythm Specialists, Fort Lauderdale

35233

University of Alabama, Birmingham

35243

Grandview Medical Center, Birmingham

43210

Ohio State University, Columbus

48073

Beaumont Health, Royal Oak

80402

Colorado Heart, Golden

85006

Banner Health, Phoenix

90404

Pacific Heart Institute, Santa Monica

94062

Sutter Health Sequoia Heart and Vascular Institute, Redwood City

98004

Evergreen Health Research/Overlake Medical Center, Bellevue

625 00

Neuron Medical, Brno

140 21

IKEM (Institute for Clinical and Experimental Medicine), Prague

150 00

Na Homolce Hospital, Prague

1105AZ

Amsterdam UMC (location AMC), Amsterdam

3435CM

St. Antonius Hospital, Nieuwegein

3015GD

Erasmus MC, Rotterdam

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Ablacon, Inc.

INDUSTRY

lead

Cortex

INDUSTRY

NCT05883631 - 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. | Biotech Hunter | Biotech Hunter