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Atrial fibrillation (AF) initially starts in a paroxysmal form, which is mainly based on the presence of triggers. Progression of AF is accompanied by structural and electrical remodelling which can typically be described as a progressive change in electrophysiological properties of the myocardium caused by cardiovascular comorbidities and AF itself. This results in complex electrical conduction disorders, which is defined as electropathology. The aim of our study is to evaluate whether an artificial intelligence (AI)-enabled ECG algorithm (on an ECG in Sinus Rhythm) can predict electropathology in patients with AF who undergo a first PVI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low score group (DNN-score = 0 - 10%) | The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. |
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| Medium score group (DNN-score = 10 - 50%) | The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. |
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| High score group (DNN-score = 50 - 100%) | The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-enabled ECG score for Atrial Fibrillation (DNN score) | Diagnostic Test | A 12-lead ECG, performed within 24 hours before the Pulmonary Vein Isolation (PVI) procedure, will be used to calculate the DNN score. (DNN score details: https://doi.org/10.1016/j.jacep.2023.04.008) |
| Measure | Description | Time Frame |
|---|---|---|
| Low voltage area | Proportion of low voltage area in the left atrium. (Defined as a threshold 0.5mV) | During atrial voltage mapping, prior to PVI procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Transition zone voltage area | Proportion of transition zone voltage area in the left atrium. (Defined as a threshold 1mV) | During atrial voltage mapping, prior to PVI procedure. |
| Conduction delay |
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Inclusion Criteria:
Exclusion Criteria:
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All patients scheduled for a PVI will be consecutively screened and enrolled in the study. The inclusions will be stratified to the DNN score.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henri M.P.B.C. Gruwez, MD | Contact | +3289212051 | henri.gruwez@zol.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Recruiting | Genk | Limburg | 3600 | Belgium |
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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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| Atrial voltage map in sinus rhythm | Diagnostic Test | An atrial voltage map will be constructed prior to the PVI procedure. |
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Number of deceleration zones in the left atrium. (Deceleration zone defined as a zone with a conduction speed of <27cm/s)
| During atrial voltage mapping, prior to PVI procedure. |
| Conduction delay score | Weighted score for conduction deceleration zones (taking in account the number of affected zones and the severity of conduction delay) | During atrial voltage mapping, prior to PVI procedure. |
| Conduction time from sinus node to Bachman bundle | Based on Local Activation Time (LAT) sampling. Defined as first point in right atrium to first point in left atrium. | During atrial voltage mapping, prior to PVI procedure. |
| Total LA conduction time | Based on LAT sampling | During atrial voltage mapping, prior to PVI procedure. |
| Left atrial appendage ejection velocity. | Measured with TEE pulsed wave doppler. | Immediately prior to PVI procedure. |
| Left atrial size | Measured on CT or MRI imaging | Prior to PVI procedure. |
| Pericardial adipose tissue volume | Measured on CT or MRI imaging | Prior to PVI procedure. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |