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

Not Applicable

Completed

Conditions: Longstanding Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Atrial Fibrillation, Persistent
Arrhythmias, Cardiac

Registration Number: NCT06260670

Lead Sponsor: Ablacon, Inc.

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful Acquisition of EGF Mapping and High Density Mapping	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 Outcome Measures

Name	Time	Method
Total Number of EGF-Identified Sources	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.

Trial Locations

Locations (1): Herz-und Diabeteszentrum NRW (Clinic of Ruhr University of Bochum)
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Bad Oeynhausen, North Rhine-Westphalia, Germany
Herz-und Diabeteszentrum NRW (Clinic of Ruhr University of Bochum)
🇩🇪Bad Oeynhausen, North Rhine-Westphalia, Germany