FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology

NCT04473963 | Completed Results

• 1 other identifier: CP-001/002
• Study Type: interventional
• Target: 85
• Locations: 3 countries
• Sites: 4

Brief Summary

This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).

Conditions

Atrial Fibrillation, Persistent

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Acute Procedure Success

  Acute Procedure Success is defined as successful elimination of significant sources of electrographic flow (EGF) through targeted radiofrequency ablation. EGF-identified sources are significant when their leading source activity is above threshold. Successful elimination is defined as reduction of the source activity of the leading source below threshold upon post-ablation remapping using EGF mapping.

  During the Procedure

• Number of Participants With Serious Adverse Events Related to the Procedure Through 7 Days

  Freedom from Serious Adverse Events (SAE) related to the procedure through 7 days following the index procedure.

  7 days

Secondary Outcomes (7)

• Number of Electrographic Flow™ (EGF) Identified Sources With Consistent Location Across Subsequent EGF-Guided Procedures

  Index Procedure until Recurrence Procedure

• Number of Participants With 12-month Freedom From AF Recurrence

  90 day - 12 months

• Average EGF Source Ablations Per Patient

  During the procedure

• Total Duration of EGF Source Ablation Per Patient

  During the procedure

• Average Fluoroscopy Time Per Patient

  During the procedure

Study Arms (3)

Randomized to Treatment: PVI + Electrographic Flow™ (EGF) Guided Ablation Therapy

EXPERIMENTAL

This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold (≥26.5%), qualifying them for randomization. Subjects randomized to the "treatment" group first received pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. After this, EGF mapping in AF was conducted and targeted radiofrequency ablation of EGF-identified source(s) was performed in the left and right atrium. The procedure is considered complete once all EGF-identified sources have been eliminated through ablation. If necessary, the procedure were concluded with cardioversion.

Device: Electrographic Flow™ guided ablation

Randomized to Control: PVI Only

NO INTERVENTION

This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold (≥26.5%), qualifying them for randomization. Subjects randomized to the "control" group received standard pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. Subjects also received EGF mapping while in AF, but no further ablation of the EGF-identified sources. The procedure were concluded with cardioversion.

Not Randomized

NO INTERVENTION

This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, but exhibited no EGF-identified sources with leading source activity above threshold (≥26.5%). Subjects received standard pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. Empiric adjunctive ablation could be performed at operator discretion. If necessary, the procedure were concluded with cardioversion.

Interventions

Electrographic Flow™ guided ablation DEVICE

In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency 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 mapping involves 1 minute recordings of unipolar electrograms from a basket catheter, which are then processed with the EGF software. Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity above the threshold (≥ 26.5%) are considered significant and targeted for ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold.

Also known as: Electrographic Flow™ Mapping Technology, OptiMap™, Ablamap®

Randomized to Treatment: PVI + Electrographic Flow™ (EGF) Guided Ablation Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias.
• Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
• Subjects with a history of documented symptomatic, persistent or longstanding persistent atrial fibrillation \< 36 months.
• Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months.
• Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of atrial fibrillation (not applicable to De Novo subjects)

You may not qualify if:

• Left atrial diameter \> 5.5 cm.
• Left ventricular ejection fraction (LVEF) \< 35%.
• Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
• Coagulopathy, bleeding diathesis or suspected procoagulant state.
• Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
• Positive pregnancy test results for female patients of childbearing potential or breast feeding.
• Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study.
• Mitral valve stenosis and/or severe mitral regurgitation.
• Valvular atrial fibrillation.
• Prosthetic valves.
• New York Heart Association (NYHA) Class IV.
• History of myocardial infarction (MI) within 3 months prior to procedure.
• Atrial septal defect (ASD) or left atrial appendage (LAA) closure device.
• Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis).
• Life expectancy \< 12 months based on medical history or the medical judgement of the investigator.

Sponsors & Collaborators

• Cortex: lead
• Ablacon, Inc.: collaborator

Study Sites (4)

Nemocnice Na Homolce Hospital

Prague, Czech Republic, 150 30, Czechia

Location

Practice Clinic Heart And Vessels

Dresden, Saxony Land, 01099, Germany

Location

University Heart and Vascular Center Hamburg

Hamburg, 20246, Germany

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

Related Publications (2)

• Reddy VY, Langbein A, Petru J, Szili-Torok T, Funasako M, Dinshaw L, Wijchers S, Rillig A, Spitzer SG, Bhagwandien R, Metzner A, Kong MH, Neuzil P. A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF). JACC Clin Electrophysiol. 2024 Aug;10(8):1856-1869. doi: 10.1016/j.jacep.2024.03.040. Epub 2024 Jun 5.

  PMID: 38842972 RESULT

• Kutinsky I, Nilsson KR, Mrlik M, Kong MH, Mehta N, Castellano S. Electrographic flow (EGF) mapping reveals sex-based differences in EGF patterns with women concentrated in phenotypes that benefit from EGF-guided ablation. J Interv Card Electrophysiol. 2026 Jan 7. doi: 10.1007/s10840-025-02184-8. Online ahead of print.

  PMID: 41498861 DERIVED

Related Links

• A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF)

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The primary limitation of the FLOW-AF trial is the small number of patients enrolled. Although a statistically significant difference was seen between Electrographic Flow guided ablation vs the control condition, this trial was not powered to detect a difference between the treatment and control groups.

Results Point of Contact

• Title: Eliza Lawrence
• Organization: Ablacon, Inc

elawrence@cortexep.com

+16507049907

Study Officials

• Petr Neuzil, MD

  Principal Investigator - Czech Republic

  PRINCIPAL INVESTIGATOR

• Tamas Szili-Torok, MD

  Principal Investigator - The Netherlands

  PRINCIPAL INVESTIGATOR

• Stefan Spitzer, MD

  Principal Investigator - Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will receive Electrographic Flow™ (EGF) mapping with Ablamap® Software. If EGF mapping identifies a source with a source activity level above threshold (≥26.5%) the subjects will be randomized to "treatment" or "control". If EGF mapping detects no source above threshold the subject will fall into the "not randomized" arm.

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: July 16, 2020
• Study Start: September 27, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: April 10, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); NL (1); DE (2)