AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation

NCT05481359 | Completed Results FDA Device

• 1 other identifier: CP-003
• Study Type: observational
• Target: 25
• Locations: 3 countries
• Sites: 5

Brief Summary

This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.

Conditions

Atrial Fibrillation, Persistent; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases

Keywords

Electrographic Flow Mapping; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute Procedure Success

  Acute Procedure Success is defined as targeting and successful elimination of significant sources of electrographic flow (EGF) through radiofrequency ablation. EGF-identified sources are significant when their leading source activity is ≥ 26%. Successful elimination is defined as reduction of the source activity of the leading source to \<26% upon post-ablation remapping using EGF mapping.

  During the procedure

Secondary Outcomes (1)

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

  90 day - 12 months

Study Arms (1)

Electrographic Flow™ guided ablation therapy

In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by EGF mapping.

Device: Electrographic Flow™ (EGF) mapping and ablation

Interventions

Electrographic Flow™ (EGF) mapping and ablation DEVICE

Electrographic Flow™ (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 algorithm (Ablamap® Software). Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity levels exceeding the recommended threshold are deemed significant and are targeted for ablation. The success of the ablation is confirmed through an EGF remap, where elimination of the source is defined as reduction of EGF source activity below the threshold.

Also known as: Ablamap®, OptiMap™

Electrographic Flow™ guided ablation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected from the investigators' general patient population with a history of atrial fibrillation that meet eligibility criteria.

You may qualify if:

• Suitable candidate for intra-cardiac mapping and ablation of 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 atrial fibrillation.

You may not qualify if:

• Subjects who are not candidates for cardiac ablation procedures.
• Pregnant or nursing.
• Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.

Sponsors & Collaborators

• Ablacon, Inc.: lead
• Cortex: collaborator

Study Sites (5)

Piedmont Healthcare

Athens, Georgia, 30606, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

Location

Medicover Hospital

Warsaw, 02-972, Poland

Location

Related Publications (3)

• Nilsson KR, Anerao A, Kong MH, Derejko P, Szili-Torok T, Goyal S, Turagam M, Verma A, Castellano S. Electrographic Flow Mapping Provides Prognosis for AF Ablation Outcomes Across Two Independent Prospective Patient Cohorts. J Clin Med. 2025 Jan 22;14(3):693. doi: 10.3390/jcm14030693.

  PMID: 39941362 BACKGROUND

• Nilsson KR, Castellano S, Kong MH, Derejko P, Szili-Torok T, Goyal SK, Wijchers S, Turagam M, Reddy VY, Verma A; other members of the AF-FLOW Global Registry Study Group. AF-FLOW Global Registry Confirms Validity of Electrographic Flow Mapping as a Phenotyping Tool for Atrial Fibrillation. J Cardiovasc Electrophysiol. 2025 Mar;36(3):589-599. doi: 10.1111/jce.16568. Epub 2025 Jan 16.

  PMID: 39817626 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

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

In this real-world registry, the decision to target EGF-identified sources was left to physician discretion. Consequently, numerous EGF-identified sources exceeding the threshold were not ablated.

Results Point of Contact

• Title: Eliza Lawrence
• Organization: Cortex, Inc

elawrence@cortexep.com

+16507049907

Study Officials

• Kent Nilsson, MD

  Piedmont Athens Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: September 12, 2022
• Primary Completion: October 27, 2022
• Study Completion: November 17, 2023
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); PL (1); US (3)