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Diagnostic Accuracy of the ATE Score for the Exclusion of Intra-atrial Thrombi Before Catheter Ablation of Atrial Fibrillation: a Confirmatory Study
In Brief
An observational study evaluating ATE score for Atrial Fibrillation and Thrombi. Completed, enrolled 3,160 participants across 15 sites in 2 countries.
Detailed Summary
Atrial fibrillation is the most frequent heart rhythm disorder. Its symptomatic forms, resistant to drug therapy, require invasive management (catheter ablation), which exposes to potentially serious complications including thromboembolic complications. Despite anticoagulant treatment, intra-atrial thrombus, which is a contraindication to catheter ablation, is detected in nearly 2 % of cases. Its diagnosis requires prior transoesophageal echocardiography, an unpleasant examination. A previous study (NCT02199080) showed that a zero ATE score, defined by no heart failure, no hypertension, no history of stroke, d-dimer \< 270 ng/mL, has a negative predictive value of 100 % for the exclusion of intra-atrial thrombus. The objective of the study is to confirm the negative predictive value, sensitivity and specificity of the ATE score for the exclusion of intra-atrial thrombus.
Study Details
Timeline
Interventions
The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus : Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (\> 270 ng/ml) = 1