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The goal of this observational study is to analyze the characteristics of left atrial electroanatomical maps in patients without a history of atrial fibrillation but with a high clinical risk of developing it, as indicated by the presence of structural heart disease or a CHA2DS2-VASc score ≥ 2 points. The study cohort will be compared to a historical cohort of patients with diagnosed atrial fibrillation in a propensity-matched fashion.
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left atrial mapping group in patients without atrial fibrillation | Inclusion criteria:
Exclusion criteria:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left atrial electroanatomical mapping | Diagnostic Test | Left atrial electroanatomical mapping (substrate and functional mapping) |
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| Measure | Description | Time Frame |
|---|---|---|
| Substrate characterization of the left atrium. | Substrate characterization will involve measuring Low Voltage (LV) and Transition Voltage (TV) Zones (LV zone voltage cut-off of <0.5mV; TV zone voltage limits within 0.5 and 1mV). These zones will be considered if they encompass an area of at least 1cm², containing ≥3 neighboring points within ≤10mm distance. The total LVZ and TVZ surfaces will be expressed as a percentage relative to the total surface area of the left atrium (excluding the pulmonary veins and the mitral annulus). A comparative analysis of substrate characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation). | 18 months |
| Functional characterization of the left atrium. | Functional analysis will rely on identifying deceleration zones characterized by isochronal crowding, defined as having ≥3 isochrones within a 1cm radius, using an 8-color scale of left atrial isochronal activation mapping. A comparative analysis of functional characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation). | 18 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of atrial fibrillation during follow-up. | Episodes diagnosed via a single-lead ECG tracing or a complete 12-lead ECG lasting at least 30 seconds, or AHRE episodes detected by any cardiac implantable electronic device (CIED), lasting at least 5 minutes. | 12 months |
| Incidence of myocardial infarction during follow-up |
Inclusion Criteria:
Exclusion criteria:
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Consecutive patients undergoing ventricular arrhythmias ablations in whom transeptal access is needed for the ablation of the targeted arrhythmia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Sarkozy, MD, PhD | Contact | 0032 02476 3657 | Andrea.Sarkozy@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Sarkozy, MD, PhD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Jette | Brussels Capital | 1090 | Belgium |
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| ID | Term |
|---|---|
| D064752 | Atrial Remodeling |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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Only type 1 myocardial infarctions, those related to acute coronary obstruction, will be considered. |
| 12 months |
| Incidence of stroke during follow-up | Stroke will be defined as any objective evidence of permanent brain, spinal cord, or retinal cell death resulting from a vascular cause, substantiated by pathological or imaging evidence, with or without accompanying clinical symptoms. | 12 months |
| Incidence of transient ischemic attack incidence during follow-up | Transient ischemic attack will be defined as a sudden, focal neurological deficit of presumed vascular origin lasting less than 24 hours. | 12 months |