Atrial Fibrillation, PersistentFLOW-AFNCT04473963

FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology

A study testing Electrographic Flow™ guided ablation in people with Atrial Fibrillation, Persistent, run by Cortex at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software). Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Atrial Fibrillation, Persistent
What is being tested?: Electrographic Flow™ guided ablation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 4 sitesin 3 countries
Study dates: 27 Sep 2019to 27 Sep 2021
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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Suitable candidate for intra-cardiac mapping and ablation of atrial 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, persistent or longstanding persistent atrial fibrillation < 36 months.
Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months.
Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of atrial fibrillation (not applicable to De Novo subjects)

Who cannot join

Left atrial diameter > 5.5 cm.
Left ventricular ejection fraction (LVEF) < 35%.
Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
Coagulopathy, bleeding diathesis or suspected procoagulant state.
Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
Positive pregnancy test results for female patients of childbearing potential or breast feeding.

Show all 16Show fewer

Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study.
Mitral valve stenosis and/or severe mitral regurgitation.
Valvular atrial fibrillation.
Prosthetic valves.
New York Heart Association (NYHA) Class IV.
History of myocardial infarction (MI) within 3 months prior to procedure.
Atrial septal defect (ASD) or left atrial appendage (LAA) closure device.
Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis).
Life expectancy < 12 months based on medical history or the medical judgement of the investigator.
Presence of any transvenous pacing, Implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) leads.

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

Germany2 sites

Practice Clinic Heart And Vessels
Dresden, Saxony Land, 01099
University Heart and Vascular Center Hamburg
Hamburg, 20246

Other trials in Germany

Czechia1 site

Nemocnice Na Homolce Hospital
Prague, Czech Republic, 150 30

Other trials in Czechia

Netherlands1 site

Erasmus Medical Center
Rotterdam, South Holland, 3015GD

Other trials in Netherlands

About this study

Official title: A Randomized Controlled Study to Evaluate the Reliability of Electrographic Flow™ (EGF) Mapping Algorithm Technology to Identify Sources of Atrial Fibrillation and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation

This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).

Read the detailed description

The objective of this study is to evaluate the reliability of Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software) to identify sources of atrial fibrillation and guide ablation therapy in patients with persistent atrial fibrillation.

Conditions: Atrial Fibrillation, Persistent
Being tested: Electrographic Flow™ guided ablation
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electrographic Flow™ guided ablationDevice
Also called Electrographic Flow™ Mapping Technology, OptiMap™, Ablamap®
In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping. 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 software. Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity above the threshold (≥ 26.5%) are considered significant and targeted for ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold.

Study groups in NCT04473963
Study group	Role	What they receive
Randomized to Treatment: PVI + Electrographic Flow™ (EGF) Guided Ablation Therapy	Experimental	This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold (≥26.5%), qualifying them for randomization. Subjects randomized to the "treatment" group first received pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. After this, EGF mapping in AF was conducted and targeted radiofrequency ablation of EGF-identified source(s) was performed in the left and right atrium. The procedure is considered complete once all EGF-identified sources have been eliminated through ablation. If necessary, the procedure were concluded with cardioversion. Receives: Device: Electrographic Flow™ guided ablation
Randomized to Control: PVI Only	No intervention	This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold (≥26.5%), qualifying them for randomization. Subjects randomized to the "control" group received standard pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. Subjects also received EGF mapping while in AF, but no further ablation of the EGF-identified sources. The procedure were concluded with cardioversion.
Not Randomized	No intervention	This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, but exhibited no EGF-identified sources with leading source activity above threshold (≥26.5%). Subjects received standard pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. Empiric adjunctive ablation could be performed at operator discretion. If necessary, the procedure were concluded with cardioversion.

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 successful elimination of significant sources of electrographic flow (EGF) through targeted radiofrequency ablation. EGF-identified sources are significant when their leading source activity is above threshold. Successful elimination is defined as reduction of the source activity of the leading source below threshold upon post-ablation remapping using EGF mapping.
Measured: During the Procedure
Number of Participants With Serious Adverse Events Related to the Procedure Through 7 Days
Freedom from Serious Adverse Events (SAE) related to the procedure through 7 days following the index procedure.
Measured: 7 days

Secondary outcomes (7)

Number of Electrographic Flow™ (EGF) Identified Sources With Consistent Location Across Subsequent EGF-Guided Procedures
This measure represents the number of Electrographic Flow™ (EGF) identified sources that remained consistent in anatomical location during subsequent EGF-guided procedures. The number and anatomical locations of EGF-identified sources for each subject were compared between the Index procedure and a subsequent EGF-guided procedure conducted ≥ 3 months later. A source was considered consistent if it was visible in the same anatomical location across both procedures.
Measured: Index Procedure until Recurrence Procedure
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. Follow-up and electrocardiographic monitoring of AF occurred at 3, 6 and 12 months through 7-day Holter recordings and ECGs.
Measured: 90 day - 12 months
Average EGF Source Ablations Per Patient
Average number of Electrographic Flow™ (EGF) source ablations per patients, defined as the number of significant EGF-identified sources with a source activity above threshold.
Measured: During the procedure
Total Duration of EGF Source Ablation Per Patient
Average total duration of radiofrequency ablation of the significant Electrographic Flow™ (EGF) identified sources per patient. Defined as the number of seconds of radiofrequency ablation spend on EGF-identified source ablation.
Measured: During the procedure
Average Fluoroscopy Time Per Patient
Average total fluoroscopy time (in minutes) of the complete electrophysiology procedure per patient.
Measured: During the procedure
Total Radiation Dose Per Patient
Average total radiation dose of the complete electrophysiology procedure, expressed in Air Kerma (AK) in mGy
Measured: During the procedure
Total Procedure Time
Total procedure time of complete electrophysiology procedure in minutes.
Measured: During the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 201927 Sep 2021

First posted16 Jul 2020
Study start27 Sep 2019
Primary completion27 Sep 2021
Study completion27 Sep 2021

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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will receive Electrographic Flow™ (EGF) mapping with Ablamap® Software. If EGF mapping identifies a source with a source activity level above threshold (≥26.5%) the subjects will be randomized to "treatment" or "control". If EGF mapping detects no source above threshold the subject will fall into the "not randomized" arm.
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04473963
Sponsor's protocol ID: CP-001/002
Acronym: FLOW-AF
Status last verified: Apr 2025
First submitted: 16 Mar 2020
Last updated: 10 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Reddy VY, Langbein A, Petru J, Szili-Torok T, Funasako M, Dinshaw L, Wijchers S, Rillig A, Spitzer SG, Bhagwandien R, Metzner A, Kong MH, Neuzil P. A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF). JACC Clin Electrophysiol. 2024 Aug;10(8):1856-1869. doi: 10.1016/j.jacep.2024.03.040. Epub 2024 Jun 5.
PubMed 38842972
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 42623431
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 Jun;69(4):637-650. doi: 10.1007/s10840-025-02184-8. Epub 2026 Jan 7.
PubMed 41498861
Verma A, Castellano S, Kong MH, Neuzil P, Szili-Torok T, Spitzer SG, Rillig A, Reddy VY. PVI-only is not enough for all patients with persistent AF: A FLOW-AF subgroup analysis. Heart Rhythm. 2025 May;22(5):1170-1178. doi: 10.1016/j.hrthm.2024.10.037. Epub 2024 Oct 22.
PubMed 39447813

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF)

All Atrial Fibrillation, Persistent trials

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 Randomized Controlled Study to Evaluate the Reliability of Electrographic Flow™ (EGF) Mapping Algorithm Technology to Identify Sources of Atrial Fibrillation and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation
ClinicalTrials.gov ID: NCT04473963
Acronym / sponsor ID: FLOW-AF / CP-001/002
Conditions: Atrial Fibrillation, Persistent
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: CortexIndustry (pharma, biotech, devices)
Collaborators: Ablacon, Inc.
Study start: 27 Sep 2019 (actual)
Primary completion: 27 Sep 2021 (actual)
Study completion: 27 Sep 2021 (actual)
First posted: 16 Jul 2020 (actual)
Results: Posted 29 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Subjects will receive Electrographic Flow™ (EGF) mapping with Ablamap® Software. If EGF mapping identifies a source with a source activity level above threshold (≥26.5%) the subjects will be randomized to "treatment" or "control". If EGF mapping detects no source above threshold the subject will fall into the "not randomized" arm.

Arm	Type	Receives
Randomized to Treatment: PVI + Electrographic Flow™ (EGF) Guided Ablation Therapy	Experimental	Device: Electrographic Flow™ guided ablationThis arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold (≥26.5%), qualifying them for randomization. Subjects randomized to the "treatment" group first received pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. After this, EGF mapping in AF was conducted and targeted radiofrequency ablation of EGF-identified source(s) was performed in the left and right atrium. The procedure is considered complete once all EGF-identified sources have been eliminated through ablation. If necessary, the procedure were concluded with cardioversion.
Randomized to Control: PVI Only	No intervention	–This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold (≥26.5%), qualifying them for randomization. Subjects randomized to the "control" group received standard pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. Subjects also received EGF mapping while in AF, but no further ablation of the EGF-identified sources. The procedure were concluded with cardioversion.
Not Randomized	No intervention	–This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, but exhibited no EGF-identified sources with leading source activity above threshold (≥26.5%). Subjects received standard pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. Empiric adjunctive ablation could be performed at operator discretion. If necessary, the procedure were concluded with cardioversion.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Suitable candidate for intra-cardiac mapping and ablation of atrial 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, persistent or longstanding persistent atrial fibrillation < 36 months.
Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months.
Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of atrial fibrillation (not applicable to De Novo subjects)

Key exclusion criteria (16 listed)

Left atrial diameter > 5.5 cm.
Left ventricular ejection fraction (LVEF) < 35%.
Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
Coagulopathy, bleeding diathesis or suspected procoagulant state.
Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation 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™ guided ablationAlso: Electrographic Flow™ Mapping Technology, OptiMap™, Ablamap®In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping. 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 software. Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity above the threshold (≥ 26.5%) are considered significant and targeted for ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold.	Device	Randomized to Treatment: PVI + Electrographic Flow™ (EGF) Guided Ablation Therapy

Primary outcome

Number of Participants With Acute Procedure Success
Time frame: During the Procedure
Acute Procedure Success is defined as successful elimination of significant sources of electrographic flow (EGF) through targeted radiofrequency ablation. EGF-identified sources are significant when their leading source activity is above threshold. Successful elimination is defined as reduction of the source activity of the leading source below threshold upon post-ablation remapping using EGF mapping.
Number of Participants With Serious Adverse Events Related to the Procedure Through 7 Days
Time frame: 7 days
Freedom from Serious Adverse Events (SAE) related to the procedure through 7 days following the index procedure.

7 secondary outcomes

Number of Electrographic Flow™ (EGF) Identified Sources With Consistent Location Across Subsequent EGF-Guided Procedures
Time frame: Index Procedure until Recurrence Procedure
Number of Participants With 12-month Freedom From AF Recurrence
Time frame: 90 day - 12 months
Average EGF Source Ablations Per Patient
Time frame: During the procedure
Total Duration of EGF Source Ablation Per Patient
Time frame: During the procedure
Average Fluoroscopy Time Per Patient
Time frame: During the procedure
Total Radiation Dose Per Patient
Time frame: During the procedure
Total Procedure Time
Time frame: During the procedure

Results and safety

Results posted to the registry on 29 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomized to Treatment: PVI + Electrographic Flow™ (EGF) Guided Ablation Therapy	22	21
Randomized to Control: PVI Only	24	23
Not Randomized	34	32

Primary outcome: Number of Participants With Acute Procedure Success

Time frame: During the Procedure. Count of participants. Unit: Participants

Measure	Randomized to Treatment: PVI + EGF Guided Ablation Therapy n = 20
Value	19

Population analysed: Per protocol population. Outcome Measure is only applicable to the group "Randomized to Treatment: PVI + EGF-Guided Ablation Therapy", because this outcome assesses the ability to eliminate EGF-identified sources through targeted source ablation. Other groups did not receive EGF-identified source ablation, and are therefore not included in analysis.

Primary outcome: Number of Participants With Serious Adverse Events Related to the Procedure Through 7 Days

Time frame: 7 days. Count of participants. Unit: Participants

Measure	Randomized to Treatment: PVI + EGF Guided Ablation Therapy n = 22	Randomized to Control: PVI Only n = 24	Not Randomized n = 34	Total n = 80
Value	0	0	2	2

Randomized to Treatment: PVI + EGF Guided Ablation Therapy vs Randomized to Control: PVI Only: p = 0.277, Chi-squared

Population analysed: ITT population

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year follow-up after index procedure. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized to Treatment: PVI + EGF Guided Ablation Therapy	0 of 22 (0%)	3 of 22 (13.6%)	0 of 22
Randomized to Control: PVI Only	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
Not Randomized	2 of 34 (5.9%)	5 of 34 (14.7%)	0 of 34

Limitations and caveats (from the sponsor): The primary limitation of the FLOW-AF trial is the small number of patients enrolled. Although a statistically significant difference was seen between Electrographic Flow guided ablation vs the control condition, this trial was not powered to detect a difference between the treatment and control groups.

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.
Results publication: PubMed 38842972Reddy VY, Langbein A, Petru J, Szili-Torok T, Funasako M, Dinshaw L, Wijchers S, Rillig A, Spitzer SG, Bhagwandien R, Metzner A, Kong MH, Neuzil P. A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF). JACC Clin Electrophysiol. 2024 Aug;10(8):1856-1869. doi: 10.1016/j.jacep.2024.03.040. Epub 2024 Jun 5.
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 39447813Verma A, Castellano S, Kong MH, Neuzil P, Szili-Torok T, Spitzer SG, Rillig A, Reddy VY. PVI-only is not enough for all patients with persistent AF: A FLOW-AF subgroup analysis. Heart Rhythm. 2025 May;22(5):1170-1178. doi: 10.1016/j.hrthm.2024.10.037. Epub 2024 Oct 22.
A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF)Link provided by the sponsor.
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.

Petr Neuzil, MD principal investigator

Principal Investigator - Czech Republic

Tamas Szili-Torok, MD principal investigator

Principal Investigator - The Netherlands

Stefan Spitzer, MD principal investigator

Principal Investigator - Germany

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Electrographic Flow™ guided ablation in people with Atrial Fibrillation, Persistent, run by Cortex at 4 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 5 inclusion and 16 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 4 sites in Germany, Czechia, Netherlands. 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 29 Jan 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). The study lists 2 primary outcomes in all. 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 NCT04473963, 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.