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

Persistent Atrial Fibrillation Clinical Trial

— FLOW EVAL-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06260670
• Other study ID #: CP004
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 28, 2022

Study information

• Verified date: May 2024
• Source: Cortex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Longstanding Persistent Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter
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).

Locations

Country	Name	City	State
Germany	Herz-und Diabeteszentrum NRW (Clinic of Ruhr University of Bochum)	Bad Oeynhausen	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Ablacon, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Successful Acquisition of EGF Mapping and High Density Mapping	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.	Intraprocedural
Secondary	Total Number of EGF-Identified Sources	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.	Intraprocedural