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

NCT ID: NCT06260670

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2022-10-28

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.

Conditions

Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation; Atrial Fibrillation, Persistent; Arrhythmias, Cardiac

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

EGF Mapping

Subjects will be treated with catheter ablation of atrial fibrillation as is clinically indicated according to standard hospital ablation procedures (pulmonary vein isolation in de novo, pulmonary vein isolation touch-up in redo).

In addition, subjects will receive electrographic flow mapping (EGF) and concomitant high density mapping to collect electrogram patterns and morphology using both mapping methods.

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Ablamap® Electrographic Flow Algorithm Technology

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ablacon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nishaki Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals, Royal Oak, MI

Philipp Sommer, MD

Role: PRINCIPAL_INVESTIGATOR

Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

Locations

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

Bad Oeynhausen, North Rhine-Westphalia, Germany

Countries

Germany

References

Sommer P, Castellano S, Ahapov K, Jansen MM, Mehta NK, Kong MH. A single-center trial of electrographic flow mapping and concomitant voltage mapping in sinus rhythm and atrial fibrillation (FLOW EVAL-AF). J Interv Card Electrophysiol. 2024 Nov 27. doi: 10.1007/s10840-024-01946-0. Online ahead of print.

Reference Type: DERIVED

PMID: 39604766 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP004

Identifier Type: -

Identifier Source: org_study_id