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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: AI-enabled ECG score for Atrial Fibrillation (DNN score); Diagnostic test: Atrial voltage map in sinus rhythm

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Henri M.P.B.C. Gruwez, MD; Phone Number: +3289212051; Email: henri.gruwez@zol.be

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuis Oost-Limburg
      • Contact: Henri Gruwez, MD; Phone Number: +3289212051; Email: henri.gruwez@zol.be
      • Contact: CTU Clinical Trial Unit; Phone Number: +3289212021; Email: CTU@zol.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients scheduled for a PVI will be consecutively screened and enrolled in the study. The inclusions will be stratified to the DNN score.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.
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.	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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Electrocardiogram; Pulmonary Vein Isolation; Deep Neural Network
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Z-2023039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No