NCT06098664

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Ziekenhuis Oost-Limburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AI-enabled ECG score for Atrial Fibrillation (DNN score)	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)
DIAGNOSTIC_TEST	Atrial voltage map in sinus rhythm	An atrial voltage map will be constructed prior to the PVI procedure.

Timeline

• Start date: 2023-06-26
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2023-10-24
• Last updated: 2023-10-24

Locations

1 site across 1 country: Belgium