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.

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Cortex · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects with all types of AF who are candidates for catheter ablation of their AF. The study will enroll up to 400 subjects in 25 centers globally.

Conditions

• Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Atrial Fibrillation Paroxysmal
• Arrhythmia
• Arrhythmias, Cardiac
• Atrial Flutter
• Atrial Fibrillation, Paroxysmal or Persistent
• Atrial Arrhythmia
• Atrial Tachycardia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-23
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-06-01
• Last updated: 2025-04-13

Locations

24 sites across 4 countries: United States, Belgium, Czechia, Netherlands

Regulatory

• FDA-regulated device study