Diagnostic Accuracy of the ATE Score for the Exclusion of Intra-atrial Thrombi Before Catheter Ablation of Atrial Fibrillation: a Confirmatory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,160
- 试验地点
- 15
- 主要终点
- Number of Patients With Atrial Thrombus and a Zero ATE Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients,
- •Patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia,
- •have signed or orally given an informed consent
排除标准
- •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,
- •Under guardianship,
- •Persons unable to give their consent,
- •Refusal to participate in the study.
研究组 & 干预措施
Atrial fibrillation
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
干预措施: ATE score (Diagnostic Test)
结局指标
主要结局
Number of Patients With Atrial Thrombus and a Zero ATE Score
时间窗: at most 48 hours before ablation
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
次要结局
- Number of Patients With Atrial Thrombus(at most 48 hours before ablation)
- Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score(at most 48 hours before ablation)
- Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score(at most 48 hours before ablation)