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Exclusion of Intra-atrial Thrombus Before Catheter Ablation

NCT03455673 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3160

Last updated 2026-03-19

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Diagnostica Stago

    collaborator INDUSTRY

  • Groupe Hospitalier de la Rochelle Ré Aunis

    lead OTHER

Principal Investigators

  • Antoine MILHEM, MD · Groupe Hospitalier de la Rochelle Ré Aunis

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2020-11-07
Completion
2020-11-07

Countries

  • France
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03455673 on ClinicalTrials.gov