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

March 2, 2026 updated by: Groupe Hospitalier de la Rochelle Ré Aunis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France
        • Service de cardiologie, Centre Hospitalier du pays d'Aix
      • Annecy, France
        • Service de cardiologie, CH Annecy Genevois
      • Brest, France
        • Service de cardiologie, CHU Brest
      • La Rochelle, France
        • Groupe Hospitalier de la Rochelle Ré Aunis
      • Le Mans, France
        • Service de cardiologie, CH Le Mans
      • Metz, France
        • Service de cardiologie, CHR Metz Thionville
      • Nantes, France
        • Service de cardiologie, Hôpital privé du Confluent
      • Nîmes, France
        • Service de cardiologie, CHU Nîmes
      • Paris, France
        • Hôpital Pitie Salpétrière
      • Pau, France
        • Centre Hospitalier de Pau
      • Rouen, France
        • Service de cardiologie, CHU Rouen
      • Saint-Etienne, France
        • Service de cardiologie, CHU Saint Etienne
      • Toulouse, France
        • Service de cardiologie, CHU Toulouse
      • Trélaze, France
        • Service de cardiologie, Clinique Saint Joseph
  • Switzerland
      • Geneva, Switzerland
        • University Hospital Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

In each centre, patient eligible for atrial fibrillation or left flutter ablation will be screened. In agreement with the physician performing the procedure, the study will be explained and proposed to the eligible patients by an investigator at the admission or at the pre-ablation consultation. It is strongly recommended to include patients consecutively in order to limit selection bias.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atrial fibrillation
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at most 48 hours before ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Atrial Thrombus
Time Frame: at most 48 hours before ablation
Patients with atrial thrombus diagnosed by pre-procedural transoesophageal
at most 48 hours before ablation
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
at most 48 hours before ablation
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
at most 48 hours before ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Collaborators

Diagnostica Stago

Investigators

  • Study Director: Antoine MILHEM, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2018

Primary Completion (Actual)

November 7, 2020

Study Completion (Actual)

November 7, 2020

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/P02/211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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