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

NCT ID: NCT02199080

Last Updated: 2023-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-28

Study Completion Date

2016-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Atrial fibrillation

D-dimer assay before ablation of atrial fibrillation

Group Type OTHER

D-dimer assay before ablation of atrial fibrillation

Intervention Type OTHER

Blood sample collection for D-dimers measurement

Interventions

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D-dimer assay before ablation of atrial fibrillation

Blood sample collection for D-dimers measurement

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Groupe Hospitalier de la Rochelle Ré Aunis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine MILHEM, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier de la Rochelle Ré Aunis

Locations

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Service de cardiologie, CH de la Région d'Annecy

Annecy, , France

Site Status

Centre Hospitalier d' Auxerre

Auxerre, , France

Site Status

Service de cardiologie, CH Avignon

Avignon, , France

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Clinique La Fourcade

Bayonne, , France

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Service de cardiologie, CHU Bordeaux

Bordeaux, , France

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Service de cardiologie, CHU Brest

Brest, , France

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Service de cardiologie, CHU Caen

Caen, , France

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Service de cardiologie, CHU Clermont Ferrand

Clermont-Ferrand, , France

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Service de cardiologie, AP Hôpital Henri Mondor

Créteil, , France

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Service de cardiologie, CHU Dijon

Dijon, , France

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Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, , France

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Service de cardiologie, CH Le Mans

Le Mans, , France

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Service de cardiologie, CHU Limoges

Limoges, , France

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Service de cardiologie, HCL Groupement Est

Lyon, , France

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Service de cardiologie, APM Hôpital de La Timone

Marseille, , France

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Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP

Marseille, , France

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Service de cardiologie, Hôpital Saint Joseph

Marseille, , France

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Service de cardiologie, Institut Jacques Cartier

Massy, , France

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Service de cardiologie, CHR Metz Thionville

Metz, , France

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Service de cardiologie, CHI Le Raincy Montfermeil

Montfermeil, , France

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Service de cardiologie, CHU Nancy

Nancy, , France

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Service de cardiologie, Nouvelles Cliniques Nantaises

Nantes, , France

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Service de cardiologie, CHU Nîmes

Nîmes, , France

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Service de cardiologie, HP Les Franciscaines

Nîmes, , France

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Service de cardiologie, AP Hôpital la Pitié Salpêtrière

Paris, , France

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Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard

Paris, , France

Site Status

Service de cardiologie, Institut Mutualiste Montsouris

Paris, , France

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Service de cardiologie, CH Pau

Pau, , France

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Service de cardiologie, CHU Poitiers

Poitiers, , France

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Service de cardiologie, CHU Rennes

Rennes, , France

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Service de cardiologie, CHU Rouen

Rouen, , France

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Service de cardiologie, Centre Cardiologique du Nord

Saint-Denis, , France

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Service de cardiologie, CHU Saint Etienne

Saint-Etienne, , France

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Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques

Toulouse, , France

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Service de cardiologie, Clinique Saint Gatien

Tours, , France

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Service de cardiologie, Clinique Saint Joseph

Trélaze, , France

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Service de cardiologie, Polyclinique Vauban

Valenciennes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 30784695 (View on PubMed)

Other Identifiers

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2013-A01700-45

Identifier Type: OTHER

Identifier Source: secondary_id

2014/P02/001

Identifier Type: -

Identifier Source: org_study_id

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