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

NCT06260670 | Completed Results FDA Device

• 1 other identifier: CP004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Electrographic Flow Mapping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Number of EGF-Identified Sources

  Intraprocedural

Study Arms (1)

EGF Mapping

EXPERIMENTAL

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.

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

Interventions

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).

Also known as: Ablamap® Electrographic Flow Algorithm Technology

EGF Mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ablacon, Inc.: lead

Study Sites (1)

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

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (2)

• Kutinsky I, Nilsson KR, Mrlik M, Kong MH, Mehta N, Castellano S. Electrographic flow (EGF) mapping reveals sex-based differences in EGF patterns with women concentrated in phenotypes that benefit from EGF-guided ablation. J Interv Card Electrophysiol. 2026 Jan 7. doi: 10.1007/s10840-025-02184-8. Online ahead of print.

  PMID: 41498861 DERIVED

• 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.

  PMID: 39604766 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eliza Lawrence
• Organization: Ablacon, Inc

elawrence@cortexep.com

+16507049907

Study Officials

• Nishaki Mehta, MD

  William Beaumont Hospitals, Royal Oak, MI

  PRINCIPAL INVESTIGATOR

• Philipp Sommer, MD

  Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: September 1, 2022
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: April 10, 2025
• Results First Posted: May 16, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)