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| Name | Class |
|---|---|
| Ablacon, Inc. | INDUSTRY |
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This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrographic Flow™ guided ablation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petr Neuzil, MD | Principal Investigator - Czech Republic | Principal Investigator |
| Tamas Szili-Torok, MD | Principal Investigator - The Netherlands | Principal Investigator |
| Stefan Spitzer, MD | Principal Investigator - Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Na Homolce Hospital | Prague | Czech Republic | 150 30 | Czechia | ||
| Practice Clinic Heart And Vessels |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38842972 | Result | 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. | |
| 41498861 |
| Label | URL |
|---|---|
| A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF) | View source |
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5 patients from the run-in cohort declined to return for protocol-mandated EGF re-mapping procedure after the initial blanking period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized to Treatment: PVI + Electrographic Flow™ (EGF) Guided Ablation Therapy | This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold, 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. |
| FG001 | Randomized to Control: PVI Only | This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold, 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. |
| FG002 | Not Randomized | This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, but exhibited no EGF-identified sources with leading source activity above threshold. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intention to Treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized to Treatment: PVI + Electrographic Flow™ (EGF) Guided Ablation Therapy | This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold, 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. |
| 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 |
| 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 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. | 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. | Posted | Count of Participants | Participants | During the Procedure |
|
1 year follow-up after index procedure
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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 | Randomized to Treatment: PVI + EGF Guided Ablation Therapy | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure after presenting in volume overloaded state | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory failure after presenting in a volume overloaded state with acute decompensated heart failure. This event was adjudicated by an independend CEC as related to the procedure, but not related to the basket catheter or EGF mapping/ablation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | Non-systematic Assessment | Hematoma in groin. All of these were adjudicated by an independent CEC as related to the procedure, but not related to the basket catheter or EGF mapping/ablation. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eliza Lawrence | Ablacon, Inc | +16507049907 | elawrence@cortexep.com |
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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 | Nov 9, 2020 | Feb 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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.
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| 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. | 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. | 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. | During the procedure |
| Average Fluoroscopy Time Per Patient | Average total fluoroscopy time (in minutes) of the complete electrophysiology procedure per patient. | During the procedure |
| Total Radiation Dose Per Patient | Average total radiation dose of the complete electrophysiology procedure, expressed in Air Kerma (AK) in mGy | During the procedure |
| Total Procedure Time | Total procedure time of complete electrophysiology procedure in minutes. | During the procedure |
| Dresden |
| Saxony Land |
| 01099 |
| Germany |
| University Heart and Vascular Center Hamburg | Hamburg | 20246 | Germany |
| Erasmus Medical Center | Rotterdam | South Holland | 3015GD | Netherlands |
| 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. |
| BG001 | Randomized to Control: PVI Only | This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold, 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. |
| BG002 | Not Randomized | This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, but exhibited no EGF-identified sources with leading source activity above threshold. 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. |
| BG003 | Total | Total of all reporting groups |
| 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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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Long-Standing Persistent Atrial Fibrillation | Count of Participants | Participants |
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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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| LA Size (cm) | Mean | Standard Deviation | cm |
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| Left Ventricular Ejection Fraction | Left ventricular ejection fraction (LVEF) is the central measure of left ventricular systolic function. LVEF is the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume). Stroke volume (SV) is calculated as the difference between end-diastolic volume (EDV) and end-systolic volume (ESV). LVEF is calculated from: LVEF: [SV/EDV] x 100 | Mean | Standard Deviation | % |
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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. |
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| Primary | 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. | ITT population | Posted | Count of Participants | Participants | 7 days |
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| Secondary | 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. | A subgroup of 12 subjects (with a total of 18 Electrographic Flow™ (EGF) identified sources) from the "Randomized to Control," "Randomized to Treatment," or "Not Randomized" groups who returned for a subsequent EGF-guided procedure ≥ 3 months later. Consistency of these sources was evaluated before any randomization/treatment occurred, making inter-group comparisons inappropriate. Groups could be combined as the focus was on source consistency over time, not treatment assignment. | Posted | Number | EGF-identified Sources | Index Procedure until Recurrence Procedure | Sources above Threshold | Sources above Threshold |
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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. Follow-up and electrocardiographic monitoring of AF occurred at 3, 6 and 12 months through 7-day Holter recordings and ECGs. | Per protocol population with completed 12 month follow-up. | Posted | Count of Participants | Participants | 90 day - 12 months |
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| Secondary | 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. | Intention to Treat of the group "Randomized to Treatment" | Posted | Mean | Standard Deviation | Source Ablations per Patient | During the procedure |
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| Secondary | 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. | Intention to Treat population | Posted | Mean | Standard Deviation | minutes | During the procedure |
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| Secondary | Average Fluoroscopy Time Per Patient | Average total fluoroscopy time (in minutes) of the complete electrophysiology procedure per patient. | Intention to Treat Population | Posted | Mean | Standard Deviation | minutes | During the procedure |
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| Secondary | Total Radiation Dose Per Patient | Average total radiation dose of the complete electrophysiology procedure, expressed in Air Kerma (AK) in mGy | Per Protocol Population | Posted | Mean | Standard Deviation | mGy | During the procedure |
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| Secondary | Total Procedure Time | Total procedure time of complete electrophysiology procedure in minutes. | Intention to Treat | Posted | Mean | Standard Deviation | minutes | During the procedure |
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| 0 |
| 22 |
| 0 |
| 22 |
| 3 |
| 22 |
| EG001 | Randomized to Control: PVI Only | 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. | 0 | 24 | 0 | 24 | 3 | 24 |
| EG002 | Not Randomized | 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. | 0 | 34 | 2 | 34 | 5 | 34 |
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| Arteriovenous fistula | Vascular disorders | Systematic Assessment | Right-sided arteriovenous fistula as a result of femoral venous access for the ablation procedure. This event was adjudicated by an independent CEC as related to the procedure, but not related to the basket catheter or EGF mapping/ablation. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Male |
|