Atrial Fibrillation, PersistentNCT05481359
AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation
An observational study of Atrial Fibrillation, Persistent and Atrial Fibrillation, run by Ablacon, Inc. at 5 sites in 3 countries.
Trial summary
This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Persistent, Atrial Fibrillation, Arrhythmias, Cardiac
- What is being tested?
- Electrographic Flow™ (EGF) mapping and ablation
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 12 Sep 2022to 17 Nov 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Subjects will be selected from the investigators' general patient population with a history of atrial fibrillation that meet eligibility criteria.
Who may be able to join
- Suitable candidate for intra-cardiac mapping and ablation of arrhythmias.
- Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
- Subjects with a history of documented symptomatic atrial fibrillation.
Who cannot join
- Subjects who are not candidates for cardiac ablation procedures.
- Pregnant or nursing.
- Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Piedmont Healthcare
Athens, Georgia, 30606
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Mount Sinai Hospital
New York, New York, 10029
About this study
Official title: A Post Market, Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using Electrographic Flow (EGF™) Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation in Real-world Setting.
This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.
Read the detailed description
The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of Electrographic Flow (EGF™) mapping with Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of EGF mapping to identify sources of atrial fibrillation (AF) and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with AF and meet inclusion/exclusion criteria will be eligible for enrollment.
- Conditions
- Atrial Fibrillation, Persistent, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
- Being tested
- Electrographic Flow™ (EGF) mapping and ablation
- Keywords
- Electrographic Flow Mapping, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrographic Flow™ (EGF) mapping and ablationDevice
Also called Ablamap®, OptiMap™
Electrographic Flow™ (EGF) mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF).
EGF mapping involves 1 minute recordings of unipolar electrograms from a basket catheter, which are then processed with the EGF algorithm (Ablamap® Software). Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity levels exceeding the recommended threshold are deemed significant and are targeted for ablation. The success of the ablation is confirmed through an EGF remap, where elimination of the source is defined as reduction of EGF source activity below the threshold.
| Study group | Role | What they receive |
|---|---|---|
| Electrographic Flow™ guided ablation therapy | In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by EGF mapping. Receives: Device: Electrographic Flow™ (EGF) mapping and ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acute Procedure Success
Acute Procedure Success is defined as targeting and successful elimination of significant sources of electrographic flow (EGF) through radiofrequency ablation. EGF-identified sources are significant when their leading source activity is ≥ 26%. Successful elimination is defined as reduction of the source activity of the leading source to <26% upon post-ablation remapping using EGF mapping.
Measured: During the procedure
Secondary outcomes (1)
Number of Participants With 12-month Freedom From AF Recurrence
This measure represents the number of subjects with freedom from documented episodes of atrial fibrillation (AF) recurrence lasting longer than 30 seconds from the 90-day post-procedure blanking period through 12 months of follow-up.
Only subjects with completed 12 month follow-up are included in this analysis.
Measured: 90 day - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start12 Sep 2022
- Primary completion27 Oct 2022
- Study completion17 Nov 2023
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 (4)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation, PersistentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ablacon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cortex
- Responsible party
- Sponsor
- Investigators
- Kent Nilsson, MD, Principal investigator, Piedmont Athens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481359
- Sponsor's protocol ID
- CP-003
- Status last verified
- Apr 2025
- First submitted
- 28 Jul 2022
- 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
Nilsson KR, Anerao A, Kong MH, Derejko P, Szili-Torok T, Goyal S, Turagam M, Verma A, Castellano S. Electrographic Flow Mapping Provides Prognosis for AF Ablation Outcomes Across Two Independent Prospective Patient Cohorts. J Clin Med. 2025 Jan 22;14(3):693. doi: 10.3390/jcm14030693.
PubMed 39941362Nilsson KR, Castellano S, Kong MH, Derejko P, Szili-Torok T, Goyal SK, Wijchers S, Turagam M, Reddy VY, Verma A; other members of the AF-FLOW Global Registry Study Group. AF-FLOW Global Registry Confirms Validity of Electrographic Flow Mapping as a Phenotyping Tool for Atrial Fibrillation. J Cardiovasc Electrophysiol. 2025 Mar;36(3):589-599. doi: 10.1111/jce.16568. Epub 2025 Jan 16.
PubMed 39817626Castellano 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 41498861
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
- A Post Market, Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using Electrographic Flow (EGF™) Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation in Real-world Setting.
- ClinicalTrials.gov ID
- NCT05481359
- Acronym / sponsor ID
- CP-003
- Conditions
- Atrial Fibrillation, Persistent, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
- Keywords
- Electrographic Flow Mapping, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ablacon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cortex
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Posted 10 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.
Detailed description
The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of Electrographic Flow (EGF™) mapping with Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of EGF mapping to identify sources of atrial fibrillation (AF) and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with AF and meet inclusion/exclusion criteria will be eligible for enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrographic Flow™ guided ablation therapy | – | Device: Electrographic Flow™ (EGF) mapping and ablationIn addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by EGF mapping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from the investigators' general patient population with a history of atrial fibrillation that meet eligibility criteria.
Key inclusion criteria (3 listed)
- Suitable candidate for intra-cardiac mapping and ablation of arrhythmias.
- Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
- Subjects with a history of documented symptomatic atrial fibrillation.
Key exclusion criteria (3 listed)
- Subjects who are not candidates for cardiac ablation procedures.
- Pregnant or nursing.
- Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.
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™ (EGF) mapping and ablationAlso: Ablamap®, OptiMap™Electrographic Flow™ (EGF) mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF). EGF mapping involves 1 minute recordings of unipolar electrograms from a basket catheter, which are then processed with the EGF algorithm (Ablamap® Software). Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity levels exceeding the recommended threshold are deemed significant and are targeted for ablation. The success of the ablation is confirmed through an EGF remap, where elimination of the source is defined as reduction of EGF source activity below the threshold. | Device | Electrographic Flow™ guided ablation therapy |
Primary outcome
Number of Participants With Acute Procedure Success
Time frame: During the procedure
Acute Procedure Success is defined as targeting and successful elimination of significant sources of electrographic flow (EGF) through radiofrequency ablation. EGF-identified sources are significant when their leading source activity is ≥ 26%. Successful elimination is defined as reduction of the source activity of the leading source to <26% upon post-ablation remapping using EGF mapping.
1 secondary outcome
Number of Participants With 12-month Freedom From AF Recurrence
Time frame: 90 day - 12 months
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.
- Background: PubMed 39941362Nilsson KR, Anerao A, Kong MH, Derejko P, Szili-Torok T, Goyal S, Turagam M, Verma A, Castellano S. Electrographic Flow Mapping Provides Prognosis for AF Ablation Outcomes Across Two Independent Prospective Patient Cohorts. J Clin Med. 2025 Jan 22;14(3):693. doi: 10.3390/jcm14030693.
- Results publication: PubMed 39817626Nilsson KR, Castellano S, Kong MH, Derejko P, Szili-Torok T, Goyal SK, Wijchers S, Turagam M, Reddy VY, Verma A; other members of the AF-FLOW Global Registry Study Group. AF-FLOW Global Registry Confirms Validity of Electrographic Flow Mapping as a Phenotyping Tool for Atrial Fibrillation. J Cardiovasc Electrophysiol. 2025 Mar;36(3):589-599. doi: 10.1111/jce.16568. Epub 2025 Jan 16.
- 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.
- 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.
Kent Nilsson, MD principal investigator
Piedmont Athens Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, Persistent and Atrial Fibrillation, run by Ablacon, Inc. at 5 sites in 3 countries.
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 3 inclusion and 3 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 5 sites in United States, Netherlands, Poland. 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 10 Apr 2025). 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 Acute Procedure Success (time frame: During the procedure). 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 NCT05481359, which also lists 4 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.