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Completed

NCT Number: NCT06260670

FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation

FLOW EVAL-AF is a prospective, observational, single center pilot trial. The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the activation patterns observed from concomitant high density mapping of those regions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herz-und Diabeteszentrum NRW (Clinic of Ruhr University of Bochum)

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

About this study

It is hypothesized that initiation and propagation of atrial fibrillation (AF) is dependent, at least in part, on rapid atrial stimulation from focal sources. It is debated whether the mechanism of arrhythmogenesis at these foci is abnormal automaticity, triggered activity, microreentry or rotational reentry. However, after activation emerges from these "driver" sites, fibrillatory conduction ensues resulting in the disorganized conduction pattern of AF. Conventional mapping systems can either achieve high spatial resolution by sequential tachycardia beats following a fixed intra-atrial activation pattern (as in macro reentrant atrial flutter), or high temporal resolution with very low spatial resolution achieved through multielectrode basket catheters. Activation mapping in AF with commercially available mapping systems has been unsuccessful in identifying driver sites because atrial activation patterns change on a beat-to-beat basis precluding the use of sequential mapping approaches, and real-time mapping with basket electrodes lacks sufficient resolution to delineate the complex patterns of conduction.

Electrographic Flow (EGF) mapping (AblaMap®, Ablacon, Inc, Wheat Ridge, CO) is a unique method to assess dominant patterns of intra-atrial conduction during ongoing atrial fibrillation and has been previously described. Recordings from a multielectrode basket catheter are analyzed for electrical activation vectors over sequential 2-second segments during a 60 second acquisition period. Patterns of reproducible vector activation are used to identify driver sources for the atrial fibrillation (AF). Multiple sources are often identified in patients with persistent AF. It is anticipated that substrate modification of these source regions will eliminate the AF drivers and result in a favorable response to catheter ablation as shown in a previously published retrospective analysis.

The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the activation patterns observed from concomitant high density (HD) mapping of those regions. FLOW EVAL-AF is a prospective, observational, single center pilot trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled to undergo elective catheter ablation of AF
  • History of persistent or longstanding persistent AF
  • Able to provide written informed consent prior to the procedure
  • Age ≥18 years

Exclusion criteria

  • Presence of a permanent pacemaker or other transvenous pacing/defibrillation leads
  • Presence of a prosthetic mitral heart valve
  • Known reversible causes of AF
  • Any cerebral ischemic event (strokes or transient ischemic attacks) which occurred during the 6-month interval preceding the consent date
  • History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
  • Unable to provide own informed consent

Treatment and study plan

Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter

Device

Subjects will receive ElectroGraphic Flow™ (EGF) mapping with Ablamap® Software and a commercially available 64-pole basket mapping catheter (FIRMap™ Catheter, Abbott Laboratories, Abbott park, IL). The FIRMap™ catheter will be inserted into the right and left atrium to acquire 1 minute recordings of electrical signals in several standardized positions, and turn these into electrographic flow (EGF) maps.

Subjects will receive concomitant high density (HD) electroanatomical mapping of these regions with the commercially available Ensite Precision mapping system and Advisor™ HD Grid mapping catheter (Abbott Laboratories, Abbott Park, IL).

Other names: Ablamap® Electrographic Flow Algorithm Technology

Primary outcomes

  1. Number of Participants With Successful Acquisition of EGF Mapping and High Density Mapping

    Time frame: Intraprocedural

    Number of participants with successful acquisition of global electrographic flow (EGF) maps from each of the right and left atria and high density electrogram acquisitions, from at least 3 basket positions in each atrium.

Secondary outcomes

  1. Total Number of EGF-Identified Sources

    Time frame: Intraprocedural

    Total number of Active Sources, identified by Electrographic Flow™ (EGF) Mapping, in the total study population.

    EGF mapping uses optical flow algorithms to identify locations in the atrium that produce excitatory waves during ongoing AF, which may be detectable for varying durations of time. Sources with an active prevalence ≥ 25% were quantified as EGF-identified sources in this study.

Sponsors and collaborators

Lead sponsor

Ablacon, Inc.

Industry

Registry information

Official study title

Electrographic Flow Mapping Electrogram Validation in Patients With Persistent Atrial Fibrillation (FLOW EVAL-AF)

Acronym: FLOW EVAL-AF

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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