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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Groupe Hospitalier de la Rochelle Ré Aunis
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: September 9, 2014
Last verified: September 2014
  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 ]

Estimated Enrollment: 2000
Study Start Date: July 2014
Estimated Study Completion Date: July 2016
Estimated 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
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

Contacts
Contact: Antoine MILHEM, MD +33 5 46 45 50 50
Contact: Caroline ALLIX-BEGUEC, PhD +33 5 46 45 50 50

Locations
France
Service de cardiologie, CH de la Région d'Annecy Not yet recruiting
Annecy, France
Principal Investigator: Antoine DOMPNIER         
Service de cardiologie, CH Avignon Recruiting
Avignon, France
Principal Investigator: Jean-Paul FAUGIER         
Clinique La Fourcade Not yet recruiting
Bayonne, France
Principal Investigator: Julien LABORDERIE         
Service de cardiologie, CHU Bordeaux Recruiting
Bordeaux, France
Contact: MAIDER PIQUET         
Principal Investigator: Frédéric SACHER         
Service de cardiologie, CHU Brest Not yet recruiting
Brest, France
Principal Investigator: Jacques MANSOURATI         
Service de cardiologie, CHU Caen Not yet recruiting
Caen, France
Principal Investigator: Paul MILLIEZ         
Service de cardiologie, CHU Clermont Ferrand Not yet recruiting
Clermont Ferrand, France
Principal Investigator: Antoine ROUX         
Principal Investigator: Yannick SALUDAS         
Service de cardiologie, AP Hôpital Henri Mondor Not yet recruiting
Créteil, France
Principal Investigator: Nicolas LELLOUCHE         
Service de cardiologie, CHU Dijon Recruiting
Dijon, France
Principal Investigator: Charles GUENANCIA         
Principal Investigator: Gabriel LAURENT         
Groupe Hospitalier de la Rochelle Ré Aunis Recruiting
La Rochelle, France, 17019
Contact: Virginie LAURENCON    +33 5 46 45 50 50      
Sub-Investigator: Cécile Duplantier-Duchêne         
Sub-Investigator: Paul Bru         
Principal Investigator: Antoine MILHEM         
Service de cardiologie, CH Le Mans Recruiting
Le Mans, France
Principal Investigator: Mathieur AMELOT         
Principal Investigator: Jean-Philippe DARMON         
Service de cardiologie, CHU Limoges Not yet recruiting
Limoges, France
Principal Investigator: Najmeddine ECHAHIDI         
Service de cardiologie, HCL Groupement Est Not yet recruiting
Lyon, France
Principal Investigator: Philippe CHEVALIER         
Service de cardiologie, APM Hôpital de La Timone Not yet recruiting
Marseille, France
Principal Investigator: Jean-Claude DEHARO         
Service de cardiologie, Hôpital Saint Joseph Not yet recruiting
Marseille, France
Principal Investigator: Julien SEITZ         
Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP Not yet recruiting
Marseille, France
Principal Investigator: Jérôme TAIEB         
Service de cardiologie, Institut Jacques Cartier Not yet recruiting
Massy, France
Principal Investigator: Jérôme HORVILLEUR         
Service de cardiologie, CHR Metz Thionville Recruiting
Metz, France
Principal Investigator: Noura ZANNAD         
Service de cardiologie, CHI Le Raincy Montfermeil Not yet recruiting
Montfermeil, France
Principal Investigator: Walid AMARA         
Service de cardiologie, CHU Nancy Not yet recruiting
Nancy, France
Principal Investigator: Christinan DE CHILLOU         
Service de cardiologie, Nouvelles Cliniques Nantaises Recruiting
Nantes, France
Principal Investigator: Sélim ABBEY         
Service de cardiologie, HP Les Franciscaines Recruiting
Nîme, France
Principal Investigator: Agustin BORTONE         
Service de cardiologie, CHU Nîmes Recruiting
Nîmes, France
Principal Investigator: Pierre WINUM         
Service de cardiologie, AP Hôpital la Pitié Salpêtrière Not yet recruiting
Paris, France
Principal Investigator: Nicolas BADENCO         
Service de cardiologie, Institut Mutualiste Montsouris Not yet recruiting
Paris, France
Principal Investigator: Clément BARS         
Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard Recruiting
Paris, France
Principal Investigator: Fabrice EXTRAMIANA         
Service de cardiologie, CH Pau Recruiting
Pau, France
Principal Investigator: Hugues BADER         
Service de cardiologie, CHU Poitiers Recruiting
Poitiers, France
Principal Investigator: Bruno DEGAND         
Service de cardiologie, CHU Rennes Not yet recruiting
Rennes, France
Principal Investigator: Dominique PAVIN         
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         
Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques Not yet recruiting
Toulouse, France
Principal Investigator: Philippe MAURY         
Service de cardiologie, Clinique Saint Gatien Recruiting
Tours, France
Principal Investigator: Olivier CESARI         
Service de cardiologie, Clinique Saint Joseph Recruiting
Trélaze, France
Principal Investigator: Frédéric TREGUER         
Service de cardiologie, Polyclinique Vauban Recruiting
Valenciennes, France
Principal Investigator: Philippe RIVAT         
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

No publications provided

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: September 9, 2014
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
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014