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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06098664
Acronym
SUSTAINER
Enrollment
60
Registered
2023-10-24
Start date
2023-06-26
Completion date
2023-12-01
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Artificial Intelligence, Deep Neural Network, Electrocardiogram, Pulmonary Vein Isolation

Brief 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.

Interventions

DIAGNOSTIC_TESTAtrial voltage map in sinus rhythm

An atrial voltage map will be constructed prior to the PVI procedure.

DIAGNOSTIC_TESTAI-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)

Sponsors

Ziekenhuis Oost-Limburg
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Low voltage areaDuring atrial voltage mapping, prior to PVI procedure.Proportion of low voltage area in the left atrium. (Defined as a threshold 0.5mV)

Secondary

MeasureTime frameDescription
Transition zone voltage areaDuring atrial voltage mapping, prior to PVI procedure.Proportion of transition zone voltage area in the left atrium. (Defined as a threshold 1mV)
Conduction delayDuring atrial voltage mapping, prior to PVI procedure.Number of deceleration zones in the left atrium. (Deceleration zone defined as a zone with a conduction speed of \<27cm/s)
Conduction delay scoreDuring atrial voltage mapping, prior to PVI procedure.Weighted score for conduction deceleration zones (taking in account the number of affected zones and the severity of conduction delay)
Pericardial adipose tissue volumePrior to PVI procedure.Measured on CT or MRI imaging
Total LA conduction timeDuring atrial voltage mapping, prior to PVI procedure.Based on LAT sampling
Left atrial appendage ejection velocity.Immediately prior to PVI procedure.Measured with TEE pulsed wave doppler.
Left atrial sizePrior to PVI procedure.Measured on CT or MRI imaging
Conduction time from sinus node to Bachman bundleDuring atrial voltage mapping, prior to PVI procedure.Based on Local Activation Time (LAT) sampling. Defined as first point in right atrium to first point in left atrium.

Countries

Belgium

Contacts

Primary ContactHenri M.P.B.C. Gruwez, MD
henri.gruwez@zol.be+3289212051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026