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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nishaki Mehta, MD | William Beaumont Hospitals, Royal Oak, MI | Principal Investigator |
| Philipp Sommer, MD | Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz-und Diabeteszentrum NRW (Clinic of Ruhr University of Bochum) | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41498861 | Derived | 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. | |
| 39604766 |
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Single Center in Germany
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| ID | Title | Description |
|---|---|---|
| FG000 | EGF Mapping Group | Subjects with Persistent Atrial Fibrillation who received Electrographic Flow mapping in the context of the FLOW EVAL-AF study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2021 |
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| Intraprocedural |
| 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. 2026 Mar;69(2):189-199. doi: 10.1007/s10840-024-01946-0. Epub 2024 Nov 27. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | EGF Mapping Group | Subjects with Persistent Atrial Fibrillation who received Electrographic Flow mapping in the context of the FLOW EVAL-AF study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Left Atrium Diameter | Mean | Standard Deviation | cm |
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| CHA2DS2-VASc score | Tool to describe risk of ischemic stroke in patients with AF. To help guide the decision to treat patients with anticoagulants. Calculated by adding the number of risk factors: Congestive Heart Failure, Hypertension, Age≥75, Diabetes, Stroke/TIA, Vascular Disease, Age 65-74 years and Female Sex. Each risk factor adds a point to the risk score, except for Age ≥ 75 years & Stroke/TIA, which both add 2 points. Score of 0 represents a patient having no additional risk factors. The ESC guidelines considers a score of 1 to be moderate risk and a score ≥ 2 to be high risk. Range: 0 (low) - 9 (high) | Mean | Standard Deviation | units on a scale [scale range: 0-9] |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Total FLOW EVAL-AF Study Population | Posted | Count of Participants | Participants | No | Intraprocedural |
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| Secondary | 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. | Total FLOW EVAL-AF Study Population | Posted | Number | EGF-identified Sources | Intraprocedural |
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Subject discharge
Adverse Events were collected until subject discharge, up to 1 week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EGF Mapping Group | Subjects with Persistent Atrial Fibrillation who received Electrographic Flow mapping in the context of the FLOW EVAL-AF study. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eliza Lawrence | Ablacon, Inc | +16507049907 | elawrence@cortexep.com |
| Apr 3, 2024 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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