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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Ziekenhuis Oost-Limburg
RECRUITING
Genk
Contact Information
Primary
Henri M.P.B.C. Gruwez, MD
henri.gruwez@zol.be
+3289212051
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2023-12-01
Participants
Target number of participants: 60
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Ziekenhuis Oost-Limburg

This content was sourced from clinicaltrials.gov