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Completed

NCT Number: NCT03455673

Exclusion of Intra-atrial Thrombus Before Catheter Ablation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombi Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de cardiologie, Centre Hospitalier du pays d'Aix, Aix-en-Provence, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATE score

Diagnostic Test

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

Primary outcomes

  1. Number of Patients With Atrial Thrombus and a Zero ATE Score

    Time frame: 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

Secondary outcomes

  1. Number of Patients With Atrial Thrombus

    Time frame: at most 48 hours before ablation

    Patients with atrial thrombus diagnosed by pre-procedural transoesophageal

  2. Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score

    Time frame: at most 48 hours before ablation

    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

  3. Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score

    Time frame: at most 48 hours before ablation

    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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Collaborators

  • Diagnostica Stago

Registry information

Official study title

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

Acronym: EXTRALUCID

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2018
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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