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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Groupe Hospitalier de la Rochelle Ré Aunis
ClinicalTrials.gov Identifier:
NCT02199080
First received: July 22, 2014
Last updated: May 12, 2016
Last verified: May 2016
  Purpose
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

Condition Intervention
Atrial Fibrillation
Other: D-dimer assay before ablation of atrial fibrillation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier de la Rochelle Ré Aunis:

Primary Outcome Measures:
  • Number of patients with atrial thrombus diagnosed by transoesophageal ultrasound [ Time Frame: up to 3 hours before ablation ] [ Designated as safety issue: No ]

Enrollment: 2506
Study Start Date: July 2014
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Atrial fibrillation
D-dimer assay before ablation of atrial fibrillation
Other: D-dimer assay before ablation of atrial fibrillation
Blood sample collection for D-dimers measurement

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02199080

Locations
France
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, France, 17019
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
Nîme, 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
Sponsors and Collaborators
Groupe Hospitalier de la Rochelle Ré Aunis
Medtronic
Investigators
Principal Investigator: Antoine MILHEM, MD Groupe Hospitalier de la Rochelle Ré Aunis
  More Information

Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
ClinicalTrials.gov Identifier: NCT02199080     History of Changes
Other Study ID Numbers: 2014/P02/001  2013-A01700-45 
Study First Received: July 22, 2014
Last Updated: May 12, 2016
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Atrial Fibrillation
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on September 29, 2016