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.

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.

Conditions

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

Sponsors & Collaborators

• Ablacon, Inc.

  collaborator INDUSTRY

• Cortex

  lead INDUSTRY

Principal Investigators

• Kent Nilsson, MD · Piedmont Athens Regional

• Lucas Boersma, Prof. MD. · St. Antonius Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-23

Primary Completion

2026-01-31

Completion

2026-01-31

FDA Device

Yes

Countries

• United States
• Belgium
• Czechia
• Netherlands

Study Locations