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| Name | Class |
|---|---|
| Cortex | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrographic Flow™ (EGF) mapping and ablation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 day - 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be selected from the investigators' general patient population with a history of atrial fibrillation that meet eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Kent Nilsson, MD | Piedmont Athens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Healthcare | Athens | Georgia | 30606 | United States | ||
| Piedmont Atlanta Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39941362 | Background | 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. | |
| 39817626 | Result | Nilsson 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Electrographic Flow™ Guided Ablation Therapy | In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects received targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping. |
| 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 | May 3, 2022 |
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| Atlanta |
| Georgia |
| 30309 |
| United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Erasmus MC | Rotterdam | South Holland | 3015GD | Netherlands |
| Medicover Hospital | Warsaw | 02-972 | Poland |
| 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. |
| Subjects With at Least One EGF-identified Source Detected | Subjects with one or more Electrographic Flow™ (EGF) identified source(s) ≥ 26% source activity |
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| Received EGF-guided Ablation | Subjects who received Electrographic Flow™ (EGF) guided ablation of one or more EGF-identified sources with an activity above threshold |
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| Did Not Receive EGF-guided Ablation | Subjects who did not receive Electrographic Flow™ (EGF) guided ablation, which included:
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| COMPLETED | Completed with 12M Follow-Up |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Electrographic Flow™ (EGF) mapping. |
| 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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| Body Mass Index, Continuous | Mean | Standard Deviation | kg/m2 |
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| CHA2DS2VASc score, Categorical | 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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| Left Atrial Diameter | Median | Inter-Quartile Range | cm |
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| Left Atrial Volume Index | Median | Inter-Quartile Range | mL/m2 |
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| Left Ventricular Ejection Fraction, Continuous | Median | Inter-Quartile Range | % |
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| Paroxysmal AF | Count of Participants | Participants |
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| Persistent Atrial Fibrillation | Count of Participants | Participants |
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| Long-standing persistent AF | Count of Participants | Participants |
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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 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. | Subjects treated optimally per protocol | Posted | Count of Participants | Participants | During the procedure |
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| Secondary | 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. | The analysis population for the secondary outcome consisted of two groups: Group 1: Subjects who received EGF-guided ablation Group 2: Subjects who did not receive EGF-guided ablation, which included:
| Posted | Count of Participants | Participants | 90 day - 12 months |
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From Index Procedure to 12 Month Follow Up
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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 | Subjects That Received EGF-guided Ablation | Subjects who received Electrographic Flow™ (EGF) guided ablation of one or more EGF-identified sources with an activity above threshold | 0 | 13 | 0 | 13 | 0 | 13 |
| EG001 | Subjects That Did Not Receive EGF-guided Ablation | Subjects who did not receive Electrographic Flow™ (EGF) guided ablation, which included:
| 0 | 12 | 1 | 12 | 1 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage of iliac vein with retroperitoneal hematoma | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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In this real-world registry, the decision to target EGF-identified sources was left to physician discretion. Consequently, numerous EGF-identified sources exceeding the threshold were not ablated.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eliza Lawrence | Cortex, Inc | +16507049907 | elawrence@cortexep.com |
| Feb 14, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Poland |
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