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Completed

NCT Number: NCT02199080

D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation

The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of intraatrial thrombus before performing an ablation of atrial fibrillation

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de cardiologie, CH de la Région d'Annecy, Annecy, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age> 18 years.
  • Patients hospitalized for ablation of atrial fibrillation or symptomatic left flutter
  • Patient informed of the study

Exclusion criteria

  • Age <18 years.
  • Patients under guardianship
  • Pregnant woman
  • Contraindication to transesophageal echocardiography
  • transesophageal echocardiography made in another center as the center of ablation
  • Refusal of the patient to participate in the study
  • Patient participating in another interventional study in which an intervention related to biomedical research is performed before the transesophageal echocardiography

Treatment and study plan

D-dimer assay before ablation of atrial fibrillation

Other

Blood sample collection for D-dimers measurement

Primary outcomes

  1. Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound

    Time frame: up to 48 hours before ablation

Secondary outcomes

  1. CHADS2 Score

    Time frame: 48 hours before ablation

    CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)

  2. Risk Factors

    Time frame: 48 hours before ablation

    variables related to the presence of atrial thrombus

  3. Atrial Thrombus Exclusion (ATE) Score

    Time frame: 48 hours before ablation

    The following thromboembolic risk factors mark 1 point if present in patient:

    • hypertension = 1 point
    • cardiac insufficiency = 1 point
    • history of stoke = 1 point
    • d-dimer level >270ng/mL = 1 point The sum corresponds to the ATE score

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Collaborators

  • Medtronic

Registry information

Official study title

Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 24, 2014
Registry last updated
Oct 30, 2023

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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