Persistent Atrial FibrillationFLOW EVAL-AFNCT06260670
FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation
A study testing Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by Ablacon, Inc. at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent
- What is being tested?
- Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2022to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herz-und Diabeteszentrum NRW (Clinic of Ruhr University of Bochum)
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
Official title: Electrographic Flow Mapping Electrogram Validation in Patients With Persistent Atrial Fibrillation (FLOW EVAL-AF)
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.
Read the 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
- Being tested
- Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter
- Keywords
- Electrographic Flow Mapping
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ CatheterDevice
Also called Ablamap® Electrographic Flow Algorithm Technology
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraprocedural
Secondary outcomes (1)
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.
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Sep 2022
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablacon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nishaki Mehta, MD, Principal investigator, William Beaumont Hospitals, Royal Oak, MIPhilipp Sommer, MD, Principal investigator, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260670
- Sponsor's protocol ID
- CP004
- Acronym
- FLOW EVAL-AF
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2024
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Castellano S, Jansen M, Boersma LVA, van der Graaf M, Kong MH, Ahapov K, Haeusser P, Funasako M, Hummel JD, Su WW. Characterization of AF Recurrence and Substrate Health by Electrographic Flow (EGF) Consistency in EGF Mapping. J Cardiovasc Electrophysiol. 2026 Aug 20. doi: 10.1111/jce.70466. Online ahead of print.
PubMed 42623431Kutinsky 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 Jun;69(4):637-650. doi: 10.1007/s10840-025-02184-8. Epub 2026 Jan 7.
PubMed 41498861Sommer 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. 2026 Mar;69(2):189-199. doi: 10.1007/s10840-024-01946-0. Epub 2024 Nov 27.
PubMed 39604766
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrographic Flow Mapping Electrogram Validation in Patients With Persistent Atrial Fibrillation (FLOW EVAL-AF)
- ClinicalTrials.gov ID
- NCT06260670
- Acronym / sponsor ID
- FLOW EVAL-AF / CP004
- Conditions
- Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Arrhythmias, Cardiac
- Keywords
- Electrographic Flow Mapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ablacon, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGF Mapping | Experimental | Device: Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ CatheterSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ CatheterAlso: Ablamap® Electrographic Flow Algorithm TechnologySubjects 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). | Device | EGF Mapping |
Primary outcome
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.
1 secondary outcome
Total Number of EGF-Identified Sources
Time frame: Intraprocedural
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42623431Castellano S, Jansen M, Boersma LVA, van der Graaf M, Kong MH, Ahapov K, Haeusser P, Funasako M, Hummel JD, Su WW. Characterization of AF Recurrence and Substrate Health by Electrographic Flow (EGF) Consistency in EGF Mapping. J Cardiovasc Electrophysiol. 2026 Aug 20. doi: 10.1111/jce.70466. Online ahead of print.
- Derived from this study: PubMed 41498861Kutinsky 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 Jun;69(4):637-650. doi: 10.1007/s10840-025-02184-8. Epub 2026 Jan 7.
- Derived from this study: PubMed 39604766Sommer 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. 2026 Mar;69(2):189-199. doi: 10.1007/s10840-024-01946-0. Epub 2024 Nov 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nishaki Mehta, MD principal investigator
William Beaumont Hospitals, Royal Oak, MI
Philipp Sommer, MD principal investigator
Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by Ablacon, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Acquisition of EGF Mapping and High Density Mapping (time frame: Intraprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260670, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.