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

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score); Diagnostic Test: Atrial voltage map in sinus rhythm

• Registration Number: NCT06098664
• Lead Sponsor: Ziekenhuis Oost-Limburg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-26
• Status Verified: 2023-10
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High score group (DNN-score = 50 - 100%)	Atrial voltage map in sinus rhythm	The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group.
Medium score group (DNN-score = 10 - 50%)	Atrial voltage map in sinus rhythm	The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group.
Low score group (DNN-score = 0 - 10%)	AI-enabled ECG score for Atrial Fibrillation (DNN score)	The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group.
Low score group (DNN-score = 0 - 10%)	Atrial voltage map in sinus rhythm	The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group.
High score group (DNN-score = 50 - 100%)	AI-enabled ECG score for Atrial Fibrillation (DNN score)	The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group.
Medium score group (DNN-score = 10 - 50%)	AI-enabled ECG score for Atrial Fibrillation (DNN score)	The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group.

Primary Outcome Measures

Name	Time	Method
Low voltage area	During atrial voltage mapping, prior to PVI procedure.	Proportion of low voltage area in the left atrium. (Defined as a threshold 0.5mV)

Secondary Outcome Measures

Name	Time	Method
Conduction delay score	During atrial voltage mapping, prior to PVI procedure.	Weighted score for conduction deceleration zones (taking in account the number of affected zones and the severity of conduction delay)
Conduction delay	During atrial voltage mapping, prior to PVI procedure.	Number of deceleration zones in the left atrium. (Deceleration zone defined as a zone with a conduction speed of \<27cm/s)
Left atrial size	Prior to PVI procedure.	Measured on CT or MRI imaging
Transition zone voltage area	During atrial voltage mapping, prior to PVI procedure.	Proportion of transition zone voltage area in the left atrium. (Defined as a threshold 1mV)
Total LA conduction time	During atrial voltage mapping, prior to PVI procedure.	Based on LAT sampling
Left atrial appendage ejection velocity.	Immediately prior to PVI procedure.	Measured with TEE pulsed wave doppler.
Conduction time from sinus node to Bachman bundle	During atrial voltage mapping, prior to PVI procedure.	Based on Local Activation Time (LAT) sampling. Defined as first point in right atrium to first point in left atrium.
Pericardial adipose tissue volume	Prior to PVI procedure.	Measured on CT or MRI imaging

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium