Exclusion of Intra-atrial Thrombus Before Catheter Ablation (EXTRALUCID)

Groupe Hospitalier de la Rochelle Ré Aunis

Status: Completed

Conditions: Atrial Fibrillation; Thrombi

Treatments: Diagnostic Test: ATE score

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03455673

2017/P02/211

Details and patient eligibility

About

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.

Enrollment: 3,160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,160 participants in 1 patient group

Atrial fibrillation

Description:

ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia

Treatment:

Diagnostic Test: ATE score