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NCT05481359

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

Completed Results posted Last updated 10 April 2025
What this trial tests

trial testing Electrographic Flow™ (EGF) mapping and ablation in Atrial Fibrillation, Persistent in 25 participants. Completed in 17 November 2023.

Timeline
12 September 2022
Primary endpoint
27 October 2022
17 November 2023

Quick facts

Lead sponsorAblacon, Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment25
Start date12 September 2022
Primary completion27 October 2022
Estimated completion17 November 2023
Sites5 locations across Netherlands, United States, Poland

Drugs / interventions tested

Conditions studied

Sponsor

Ablacon, Inc.

Who can join

18 and older, any sex, with Atrial Fibrillation, Persistent or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Acute Procedure Success Primary · During the procedure

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.

GroupValue95% CI
Subjects With EGF Identified Sources13
Number of Participants With 12-month Freedom From AF Recurrence Secondary · 90 day - 12 months

This measure represents the number of subjects with freedom from documented episodes of atrial fibrillation (AF) recurrence lasting longer than 30 seconds from the 90-day post-procedure blanking period through 12 months of follow-up. Only subjects with completed 12 month follow-up are included in this analysis.

GroupValue95% CI
Subjects That Received EGF-guided Ablation8
Subjects That Did Not Receive EGF-guided Ablation6

Adverse events — posted to ClinicalTrials.gov

Time frame: From Index Procedure to 12 Month Follow Up. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Subjects That Received EGF-guided Ablation
Serious: 0/13 (0%)
Deaths: 0/13
Subjects That Did Not Receive EGF-guided Ablation
Serious: 1/12 (8%)
Deaths: 0/12

Serious adverse events (1 terms)

ReactionSystemSubjects That Received EGF…Subjects That Did Not Rece…
Hemorrhage of iliac vein with retroperitoneal hematomaVascular disorders
Other adverse events (1 terms — click to expand)

ReactionSystemSubjects That Received EGF…Subjects That Did Not Rece…
Urinary Tract InfectionRenal and urinary disorders

Most-reported serious reactions: Hemorrhage of iliac vein with retroperitoneal hematoma.

Data from ClinicalTrials.gov NCT05481359 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. AF-FLOW Global Registry Confirms Validity of Electrographic Flow Mapping as a Phenotyping Tool for Atrial Fibrillation.
    Nilsson KR, Castellano S, Kong MH, Derejko P, et al · · 2025 · cited 3× · PMID 39817626 · DOI 10.1111/jce.16568
  2. Electrographic Flow Mapping Provides Prognosis for AF Ablation Outcomes Across Two Independent Prospective Patient Cohorts.
    Nilsson KR, Anerao A, Kong MH, Derejko P, et al · · 2025 · cited 2× · PMID 39941362 · DOI 10.3390/jcm14030693
  3. Electrographic flow (EGF) mapping reveals sex-based differences in EGF patterns with women concentrated in phenotypes that benefit from EGF-guided ablation.
    Kutinsky I, Nilsson KR, Mrlik M, Kong MH, et al · · 2026 · PMID 41498861 · DOI 10.1007/s10840-025-02184-8

Verify or expand the search:

Other recruiting trials for Atrial Fibrillation, Persistent

Currently open trials in the same condition.

Other Ablacon, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05481359.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing