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

East Limburg Hospital

Status: Enrolling

Conditions: Atrial Fibrillation

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

Study type: Observational

Funder types: Other

Identifiers

NCT06098664

Z-2023039

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Low score group (DNN-score = 0 - 10%)

Description:

The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group.

Treatment:

Diagnostic Test: Atrial voltage map in sinus rhythm

Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score)

Medium score group (DNN-score = 10 - 50%)

Description:

The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group.

Treatment:

Diagnostic Test: Atrial voltage map in sinus rhythm

Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score)

High score group (DNN-score = 50 - 100%)

Description:

The inclusions will be stratified to the deep neural network (DNN) score. The study will enrol 20 patients in each group.

Treatment:

Diagnostic Test: Atrial voltage map in sinus rhythm

Diagnostic Test: AI-enabled ECG score for Atrial Fibrillation (DNN score)