Exclusion of Intra-atrial Thrombus Before Catheter Ablation
| Condition | Atrial Fibrillation, Thrombi |
|---|---|
| Phase | N/A |
| Sponsor | Groupe Hospitalier de la Rochelle Ré Aunis |
| Status | Completed |
| Enrollment | 3,160 participants |
| Interventions | ATE score |
| Start date | Sep 18, 2018 |
| Completion date | Nov 7, 2020 |
| Results posted | Dec 22, 2023 |
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.
Number of Patients With Atrial Thrombus and a Zero ATE Score
| Atrial Fibrillation | 2 Participants |
|---|---|
| Atrial Fibrillation | 816 Participants |
| Atrial Fibrillation | 27 Participants |
| Atrial Fibrillation | 2227 Participants |
Open in BENITIONS View on ClinicalTrials.gov
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