D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation
Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale
2 other identifiers
interventional
2,506
1 country
37
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Jul 2014
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2014
CompletedFirst Posted
Study publicly available on registry
July 24, 2014
CompletedStudy Start
First participant enrolled
July 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
February 15, 2019
CompletedOctober 30, 2023
October 1, 2023
1.4 years
July 22, 2014
February 28, 2018
October 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound
up to 48 hours before ablation
Secondary Outcomes (3)
CHADS2 Score
48 hours before ablation
Risk Factors
48 hours before ablation
Atrial Thrombus Exclusion (ATE) Score
48 hours before ablation
Study Arms (1)
Atrial fibrillation
OTHERD-dimer assay before ablation of atrial fibrillation
Interventions
Blood sample collection for D-dimers measurement
Eligibility Criteria
You may qualify if:
- Age\> 18 years.
- Patients hospitalized for ablation of atrial fibrillation or symptomatic left flutter
- Patient informed of the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Groupe Hospitalier de la Rochelle Ré Aunislead
- Medtroniccollaborator
Study Sites (37)
Service de cardiologie, CH de la Région d'Annecy
Annecy, France
Centre Hospitalier d' Auxerre
Auxerre, France
Service de cardiologie, CH Avignon
Avignon, France
Clinique La Fourcade
Bayonne, France
Service de cardiologie, CHU Bordeaux
Bordeaux, France
Service de cardiologie, CHU Brest
Brest, France
Service de cardiologie, CHU Caen
Caen, France
Service de cardiologie, CHU Clermont Ferrand
Clermont-Ferrand, France
Service de cardiologie, AP Hôpital Henri Mondor
Créteil, France
Service de cardiologie, CHU Dijon
Dijon, France
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, 17019, France
Service de cardiologie, CH Le Mans
Le Mans, France
Service de cardiologie, CHU Limoges
Limoges, France
Service de cardiologie, HCL Groupement Est
Lyon, France
Service de cardiologie, APM Hôpital de La Timone
Marseille, France
Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP
Marseille, France
Service de cardiologie, Hôpital Saint Joseph
Marseille, France
Service de cardiologie, Institut Jacques Cartier
Massy, France
Service de cardiologie, CHR Metz Thionville
Metz, France
Service de cardiologie, CHI Le Raincy Montfermeil
Montfermeil, France
Service de cardiologie, CHU Nancy
Nancy, France
Service de cardiologie, Nouvelles Cliniques Nantaises
Nantes, France
Service de cardiologie, CHU Nîmes
Nîmes, France
Service de cardiologie, HP Les Franciscaines
Nîmes, France
Service de cardiologie, AP Hôpital la Pitié Salpêtrière
Paris, France
Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard
Paris, France
Service de cardiologie, Institut Mutualiste Montsouris
Paris, France
Service de cardiologie, CH Pau
Pau, France
Service de cardiologie, CHU Poitiers
Poitiers, France
Service de cardiologie, CHU Rennes
Rennes, France
Service de cardiologie, CHU Rouen
Rouen, France
Service de cardiologie, Centre Cardiologique du Nord
Saint-Denis, France
Service de cardiologie, CHU Saint Etienne
Saint-Etienne, France
Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques
Toulouse, France
Service de cardiologie, Clinique Saint Gatien
Tours, France
Service de cardiologie, Clinique Saint Joseph
Trélaze, France
Service de cardiologie, Polyclinique Vauban
Valenciennes, France
Related Publications (1)
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.
PMID: 30784695RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Antoine Milhem
- Organization
- Groupe Hospitalier de la Rochelle Ré Aunis
Study Officials
- PRINCIPAL INVESTIGATOR
Antoine MILHEM, MD
Groupe Hospitalier de la Rochelle Ré Aunis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2014
First Posted
July 24, 2014
Study Start
July 28, 2014
Primary Completion
January 1, 2016
Study Completion
May 1, 2016
Last Updated
October 30, 2023
Results First Posted
February 15, 2019
Record last verified: 2023-10