Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Official Title
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Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score)
* Diagnostic Test: Atrial voltage map in sinus rhythm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed and dated informed consent. First PVI-procedure Age is 18 years or higher. 12-lead ECG available in SR during the last 14 days. Exclusion Criteria: Mitral insufficiency of grade 3 or 4. Participating in another study that may interfere with participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low score group (DNN-score = 0 - 10%)<br>The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. | Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score)<br>* 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)<br>Diagnostic Test: Atrial voltage map in sinus rhythm<br>* An atrial voltage map will be constructed prior to the PVI procedure.<br>|
| Medium score group (DNN-score = 10 - 50%)<br>The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. | Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score)<br>* 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)<br>Diagnostic Test: Atrial voltage map in sinus rhythm<br>* An atrial voltage map will be constructed prior to the PVI procedure.<br>|
| High score group (DNN-score = 50 - 100%)<br>The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group. | Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score)<br>* 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)<br>Diagnostic Test: Atrial voltage map in sinus rhythm<br>* An atrial voltage map will be constructed prior to the PVI procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Intelligence, Deep Neural Network, Electrocardiogram, Pulmonary Vein Isolation