Atrial Fibrillation Clinical Trial
Official title:
Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale
| Verified date | October 2023 |
| Source | Groupe Hospitalier de la Rochelle Ré Aunis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 2506 |
| Est. completion date | May 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe Hospitalier de la Rochelle Ré Aunis | Medtronic |
France,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound | up to 48 hours before ablation | ||
| Secondary | 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) | 48 hours before ablation | |
| Secondary | Risk Factors | variables related to the presence of atrial thrombus | 48 hours before ablation | |
| Secondary | 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 |
48 hours before ablation |
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