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

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ClinicalTrials.gov Identifier: NCT03455673
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Diagnostica Stago
Information provided by (Responsible Party):
Groupe Hospitalier de la Rochelle Ré Aunis

Brief 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.


Condition or disease Intervention/treatment
Atrial Fibrillation Thrombi Diagnostic Test: ATE score

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Diagnostic Accuracy of the ATE Score for the Exclusion of Intra-atrial Thrombi Before Catheter Ablation of Atrial Fibrillation: a Confirmatory Study
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  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


Secondary Outcome Measures :
  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

  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


Biospecimen Retention:   Samples Without DNA
Peripheral blood sample is collected for d-dimer assay at the inclusion. Frozen samples will be used to constitute a plasma bank to further confirm the study performances with other D-dimer assays.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455673


Contacts
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Contact: Caroline ALLIX-BEGUEC, Ph.D. +33516494246 caroline.allix-beguec@ch-larochelle.fr
Contact: Virginie LAURENCON, MSc +33516494165 virginie.laurencon@ch-larochelle.fr

Locations
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France
Service de cardiologie, Centre Hospitalier du pays d'Aix Recruiting
Aix en Provence, France
Principal Investigator: Jérôme TAIEB         
Service de cardiologie, CH Annecy Genevois Recruiting
Annecy, France
Principal Investigator: Antoine DOMPNIER, MD         
Sub-Investigator: Chrystelle AKRET, MD         
Sub-Investigator: Pierre FREY, MD         
Sub-Investigator: Didier IRLES, MD         
Centre hospitalier de Montfavet Not yet recruiting
Avignon, France
Contact: Saïda CHEGGOUR, MD         
Service de cardiologie, CH Avignon Recruiting
Avignon, France
Principal Investigator: Saïda CHEGGOUR         
Service de cardiologie, CHU Brest Recruiting
Brest, France
Principal Investigator: Jacques MANSOURATI         
Groupe Hospitalier de la Rochelle Ré Aunis Recruiting
La Rochelle, France
Contact: Antoine Milhem, MD         
Sub-Investigator: Cécile Duplantier, MD         
Sub-Investigator: Paul Bru, MD         
Service de cardiologie, CH Le Mans Recruiting
Le Mans, France
Principal Investigator: Mathieur AMELOT         
Service de cardiologie, APHM Not yet recruiting
Marseille, France
Principal Investigator: Jean Claude DEHARO, MD         
Service de cardiologie, CHR Metz Thionville Recruiting
Metz, France
Principal Investigator: Noura ZANNAD         
Centre Hospitalier Universitaire de Nancy Recruiting
Nancy, France
Contact: Arnaud OLIVIER, MD         
Service de cardiologie, Hôpital privé du Confluent Not yet recruiting
Nantes, France
Principal Investigator: Sélim ABBEY         
Service de cardiologie, CHU Nîmes Recruiting
Nîmes, France
Principal Investigator: Jérôme TAIEB, MD         
Centre Hospitalier de Pau Recruiting
Pau, France
Contact: Hugues BADER         
Service de cardiologie, CHU Rouen Recruiting
Rouen, France
Principal Investigator: Frédéric ANSELME         
Principal Investigator: Arnaud SAVOURE         
Service de cardiologie, Centre Cardiologique du Nord Not yet recruiting
Saint Denis, France
Principal Investigator: Olivier PIOT         
Service de cardiologie, CHU Saint Etienne Recruiting
Saint Etienne, France
Principal Investigator: Antoine Da Costa         
Centre Cardiologique du Nord Not yet recruiting
Saint-Denis, France
Contact: Olivier PIOT, MD         
Service de cardiologie, CHU Toulouse Recruiting
Toulouse, France
Principal Investigator: Philippe MAURY, MD         
Sub-Investigator: Anne ROLLIN         
Service de cardiologie, Clinique Saint Joseph Recruiting
Trélaze, France
Principal Investigator: Frédéric TREGUER         
Service de cardiologie, Polyclinique Vauban Not yet recruiting
Valenciennes, France
Principal Investigator: Zouheir SOUISSI         
Italy
Eurosanità SPA Not yet recruiting
Roma, Italy
Contact: Stefano LINO, MD         
Città della Salute e della Scienza Hospital Not yet recruiting
Torino, Italy
Principal Investigator: Matteo ANSELMINO, MD         
Switzerland
University Hospital Geneva Recruiting
Geneva, Switzerland
Principal Investigator: Dipen SHAH, MD         
Sponsors and Collaborators
Groupe Hospitalier de la Rochelle Ré Aunis
Diagnostica Stago
Investigators
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Study Director: Antoine MILHEM, MD Groupe Hospitalier de la Rochelle Ré Aunis

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Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
ClinicalTrials.gov Identifier: NCT03455673     History of Changes
Other Study ID Numbers: 2017/P02/211
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases