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

Atrial Fibrillation Clinical Trial

— SUSTAINER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06098664
• Other study ID #: Z-2023039
• Status: Recruiting
• Start date: June 26, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: Henri M.P.B.C. Gruwez, MD
• Phone: +3289212051
• Email: henri.gruwez[@]zol.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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)
• Atrial voltage map in sinus rhythm
An atrial voltage map will be constructed prior to the PVI procedure.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Total LA conduction time	Based on LAT sampling	During atrial voltage mapping, prior to PVI procedure.
Secondary	Left atrial appendage ejection velocity.	Measured with TEE pulsed wave doppler.	Immediately prior to PVI procedure.
Secondary	Left atrial size	Measured on CT or MRI imaging	Prior to PVI procedure.
Secondary	Pericardial adipose tissue volume	Measured on CT or MRI imaging	Prior to PVI procedure.