Exclusion of Intra-atrial Thrombus Before Catheter Ablation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Thrombi, Atrial Fibrillation

Intervention / Treatment
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* Diagnostic Test: ATE score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, Patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia, have signed or orally given an informed consent Exclusion Criteria: Contraindication to transoesophageal echocardiography, Transoesophageal echocardiography made in another centre than the centre of ablation, Pregnant women, parturient mothers and nursing mothers, Lives in an institution on court or authority order, Severely altered psychological health, Persons leaving in health or social establishment, Minors, Under guardianship, Persons unable to give their consent, Refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atrial fibrillation<br>ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia | Diagnostic Test: ATE score<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Atrial Thrombus and a Zero ATE Score | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, without hypertension, heart failure, history of stroke and a plasma d-dimer level < 270 ng/ml ATE : Atrial Thrombus Exclusion minimum value = 0 maximum value = 4, patient at higher risk of atrial thrombus | at most 48 hours before ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Atrial Thrombus | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal | at most 48 hours before ablation | 
| Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, and without congestive heart failure, hypertension, diabetes mellitus, vascular disease [previous myocardial infarction, peripheral arterial disease or aortic plaque], history of stroke or transient ischemic attack, aged under 75, and male minimum value = 0 maximum value = 10, at most risk of stroke | at most 48 hours before ablation | 
| Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, and without congestive heart failure, hypertension, diabetes mellitus, history of stroke or transient ischemic attack, and aged under 75 minimum value = 0 maximum value = 6, at most risk of stroke | at most 48 hours before ablation |