Clinical trial NCT02199080: D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation
Official title: Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2014-07-24
Enrollment: 2506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound
timeFrame: up to 48 hours before ablation
Secondary outcomes:
measure: CHADS2 Score
timeFrame: 48 hours before ablation
measure: Risk Factors
timeFrame: 48 hours before ablation
measure: Atrial Thrombus Exclusion (ATE) Score
timeFrame: 48 hours before ablation
Other outcomes:
Locations:
city: Annecy
country: France
facility: Service de cardiologie, CH de la Région d'Annecy
city: Auxerre
country: France
facility: Centre Hospitalier d' Auxerre
city: Avignon
country: France
facility: Service de cardiologie, CH Avignon
city: Bayonne
country: France
facility: Clinique La Fourcade
city: Bordeaux
country: France
facility: Service de cardiologie, CHU Bordeaux
city: Brest
country: France
facility: Service de cardiologie, CHU Brest
city: Caen
country: France
facility: Service de cardiologie, CHU Caen
city: Clermont Ferrand
country: France
facility: Service de cardiologie, CHU Clermont Ferrand
city: Créteil
country: France
facility: Service de cardiologie, AP Hôpital Henri Mondor
city: Dijon
country: France
facility: Service de cardiologie, CHU Dijon
city: La Rochelle
country: France
facility: Groupe Hospitalier de la Rochelle Ré Aunis
city: Le Mans
country: France
facility: Service de cardiologie, CH Le Mans
city: Limoges
country: France
facility: Service de cardiologie, CHU Limoges
city: Lyon
country: France
facility: Service de cardiologie, HCL Groupement Est
city: Marseille
country: France
facility: Service de cardiologie, APM Hôpital de La Timone
city: Marseille
country: France
facility: Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP
city: Marseille
country: France
facility: Service de cardiologie, Hôpital Saint Joseph
city: Massy
country: France
facility: Service de cardiologie, Institut Jacques Cartier
city: Metz
country: France
facility: Service de cardiologie, CHR Metz Thionville
city: Montfermeil
country: France
facility: Service de cardiologie, CHI Le Raincy Montfermeil
city: Nancy
country: France
facility: Service de cardiologie, CHU Nancy
city: Nantes
country: France
facility: Service de cardiologie, Nouvelles Cliniques Nantaises
city: Nîmes
country: France
facility: Service de cardiologie, CHU Nîmes
city: Nîmes
country: France
facility: Service de cardiologie, HP Les Franciscaines
city: Paris
country: France
facility: Service de cardiologie, AP Hôpital la Pitié Salpêtrière
city: Paris
country: France
facility: Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard
city: Paris
country: France
facility: Service de cardiologie, Institut Mutualiste Montsouris
city: Pau
country: France
facility: Service de cardiologie, CH Pau
city: Poitiers
country: France
facility: Service de cardiologie, CHU Poitiers
city: Rennes
country: France
facility: Service de cardiologie, CHU Rennes
city: Rouen
country: France
facility: Service de cardiologie, CHU Rouen
city: Saint Denis
country: France
facility: Service de cardiologie, Centre Cardiologique du Nord
city: Saint Etienne
country: France
facility: Service de cardiologie, CHU Saint Etienne
city: Toulouse
country: France
facility: Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques
city: Tours
country: France
facility: Service de cardiologie, Clinique Saint Gatien
city: Trélaze
country: France
facility: Service de cardiologie, Clinique Saint Joseph
city: Valenciennes
country: France
facility: Service de cardiologie, Polyclinique Vauban
Study officials:
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Antoine MILHEM, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milhem A, Ingrand P, Treguer F, Cesari O, Da Costa A, Pavin D, Rivat P, Badenco N, Abbey S, Zannad N, Winum PF, Mansourati J, Maury P, Bader H, Savoure A, Sacher F, Andronache M, Allix-Beguec C, De Chillou C, Anselme F; ATE Study Group. Exclusion of Intra-Atrial Thrombus Diagnosis Using D-Dimer Assay Before Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):223-230. doi: 10.1016/j.jacep.2018.09.009. Epub 2018 Nov 1.