Back to resultsD-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
D-dimer assay before ablation of atrial fibrillation
Sponsored by
About this trial
This is an interventional diagnostic trial for 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
Sites / Locations
- Service de cardiologie, CH de la Région d'Annecy
- Centre Hospitalier d' Auxerre
- Service de cardiologie, CH Avignon
- Clinique La Fourcade
- Service de cardiologie, CHU Bordeaux
- Service de cardiologie, CHU Brest
- Service de cardiologie, CHU Caen
- Service de cardiologie, CHU Clermont Ferrand
- Service de cardiologie, AP Hôpital Henri Mondor
- Service de cardiologie, CHU Dijon
- Groupe Hospitalier de la Rochelle Ré Aunis
- Service de cardiologie, CH Le Mans
- Service de cardiologie, CHU Limoges
- Service de cardiologie, HCL Groupement Est
- Service de cardiologie, APM Hôpital de La Timone
- Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP
- Service de cardiologie, Hôpital Saint Joseph
- Service de cardiologie, Institut Jacques Cartier
- Service de cardiologie, CHR Metz Thionville
- Service de cardiologie, CHI Le Raincy Montfermeil
- Service de cardiologie, CHU Nancy
- Service de cardiologie, Nouvelles Cliniques Nantaises
- Service de cardiologie, CHU Nîmes
- Service de cardiologie, HP Les Franciscaines
- Service de cardiologie, AP Hôpital la Pitié Salpêtrière
- Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard
- Service de cardiologie, Institut Mutualiste Montsouris
- Service de cardiologie, CH Pau
- Service de cardiologie, CHU Poitiers
- Service de cardiologie, CHU Rennes
- Service de cardiologie, CHU Rouen
- Service de cardiologie, Centre Cardiologique du Nord
- Service de cardiologie, CHU Saint Etienne
- Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques
- Service de cardiologie, Clinique Saint Gatien
- Service de cardiologie, Clinique Saint Joseph
- Service de cardiologie, Polyclinique Vauban
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Atrial fibrillation
Arm Description
D-dimer assay before ablation of atrial fibrillation
Outcomes
Primary Outcome Measures
Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound
Secondary Outcome Measures
CHADS2 Score
CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)
Risk Factors
variables related to the presence of atrial thrombus
Atrial Thrombus Exclusion (ATE) Score
The following thromboembolic risk factors mark 1 point if present in patient:
hypertension = 1 point
cardiac insufficiency = 1 point
history of stoke = 1 point
d-dimer level >270ng/mL = 1 point The sum corresponds to the ATE score
Full Information
NCT ID
NCT02199080
First Posted
July 22, 2014
Last Updated
October 8, 2018
Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT02199080
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 28, 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2506 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atrial fibrillation
Arm Type
Other
Arm Description
D-dimer assay before ablation of atrial fibrillation
Intervention Type
Other
Intervention Name(s)
D-dimer assay before ablation of atrial fibrillation
Intervention Description
Blood sample collection for D-dimers measurement
Primary Outcome Measure Information:
Title
Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound
Time Frame
up to 48 hours before ablation
Secondary Outcome Measure Information:
Title
CHADS2 Score
Description
CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)
Time Frame
48 hours before ablation
Title
Risk Factors
Description
variables related to the presence of atrial thrombus
Time Frame
48 hours before ablation
Title
Atrial Thrombus Exclusion (ATE) Score
Description
The following thromboembolic risk factors mark 1 point if present in patient:
hypertension = 1 point
cardiac insufficiency = 1 point
history of stoke = 1 point
d-dimer level >270ng/mL = 1 point The sum corresponds to the ATE score
Time Frame
48 hours before ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine MILHEM, MD
Organizational Affiliation
Groupe Hospitalier de la Rochelle Ré Aunis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de cardiologie, CH de la Région d'Annecy
City
Annecy
Country
France
Facility Name
Centre Hospitalier d' Auxerre
City
Auxerre
Country
France
Facility Name
Service de cardiologie, CH Avignon
City
Avignon
Country
France
Facility Name
Clinique La Fourcade
City
Bayonne
Country
France
Facility Name
Service de cardiologie, CHU Bordeaux
City
Bordeaux
Country
France
Facility Name
Service de cardiologie, CHU Brest
City
Brest
Country
France
Facility Name
Service de cardiologie, CHU Caen
City
Caen
Country
France
Facility Name
Service de cardiologie, CHU Clermont Ferrand
City
Clermont Ferrand
Country
France
Facility Name
Service de cardiologie, AP Hôpital Henri Mondor
City
Créteil
Country
France
Facility Name
Service de cardiologie, CHU Dijon
City
Dijon
Country
France
Facility Name
Groupe Hospitalier de la Rochelle Ré Aunis
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
Service de cardiologie, CH Le Mans
City
Le Mans
Country
France
Facility Name
Service de cardiologie, CHU Limoges
City
Limoges
Country
France
Facility Name
Service de cardiologie, HCL Groupement Est
City
Lyon
Country
France
Facility Name
Service de cardiologie, APM Hôpital de La Timone
City
Marseille
Country
France
Facility Name
Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP
City
Marseille
Country
France
Facility Name
Service de cardiologie, Hôpital Saint Joseph
City
Marseille
Country
France
Facility Name
Service de cardiologie, Institut Jacques Cartier
City
Massy
Country
France
Facility Name
Service de cardiologie, CHR Metz Thionville
City
Metz
Country
France
Facility Name
Service de cardiologie, CHI Le Raincy Montfermeil
City
Montfermeil
Country
France
Facility Name
Service de cardiologie, CHU Nancy
City
Nancy
Country
France
Facility Name
Service de cardiologie, Nouvelles Cliniques Nantaises
City
Nantes
Country
France
Facility Name
Service de cardiologie, CHU Nîmes
City
Nîmes
Country
France
Facility Name
Service de cardiologie, HP Les Franciscaines
City
Nîmes
Country
France
Facility Name
Service de cardiologie, AP Hôpital la Pitié Salpêtrière
City
Paris
Country
France
Facility Name
Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard
City
Paris
Country
France
Facility Name
Service de cardiologie, Institut Mutualiste Montsouris
City
Paris
Country
France
Facility Name
Service de cardiologie, CH Pau
City
Pau
Country
France
Facility Name
Service de cardiologie, CHU Poitiers
City
Poitiers
Country
France
Facility Name
Service de cardiologie, CHU Rennes
City
Rennes
Country
France
Facility Name
Service de cardiologie, CHU Rouen
City
Rouen
Country
France
Facility Name
Service de cardiologie, Centre Cardiologique du Nord
City
Saint Denis
Country
France
Facility Name
Service de cardiologie, CHU Saint Etienne
City
Saint Etienne
Country
France
Facility Name
Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques
City
Toulouse
Country
France
Facility Name
Service de cardiologie, Clinique Saint Gatien
City
Tours
Country
France
Facility Name
Service de cardiologie, Clinique Saint Joseph
City
Trélaze
Country
France
Facility Name
Service de cardiologie, Polyclinique Vauban
City
Valenciennes
Country
France
12. IPD Sharing Statement
Learn more about this trial
D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation
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