Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation
NCT ID: NCT06098664
Last Updated: 2023-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2023-06-26
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* First PVI-procedure
* Age is 18 years or higher.
* 12-lead ECG available in SR during the last 14 days.
Exclusion Criteria
* Participating in another study that may interfere with participation in this study
18 Years
ALL
No
Sponsors
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Ziekenhuis Oost-Limburg
OTHER
Responsible Party
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Laurent Pison
Clinical professor
Locations
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Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Z-2023039
Identifier Type: -
Identifier Source: org_study_id
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