NCT03455673

Exclusion of Intra-atrial Thrombus Before Catheter Ablation

Diagnostic Accuracy of the ATE Score for the Exclusion of Intra-atrial Thrombi Before Catheter Ablation of Atrial Fibrillation: a Confirmatory Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,160 (actual)
• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Thrombi

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ATE score	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

Timeline

• Start date: 2018-09-18
• Primary completion: 2020-11-07
• Completion: 2020-11-07
• First posted: 2018-03-06
• Last updated: 2026-03-19
• Results posted: 2023-12-22

Locations

15 sites across 2 countries: France, Switzerland