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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01700-45 | Other Identifier | French National Agency for Medicines/Health Products Safety |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial fibrillation | Other | D-dimer assay before ablation of atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-dimer assay before ablation of atrial fibrillation | Other | Blood sample collection for D-dimers measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound | up to 48 hours before ablation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Risk Factors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine MILHEM, MD | Groupe Hospitalier de la Rochelle Ré Aunis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de cardiologie, CH de la Région d'Annecy | Annecy | France | ||||
| Centre Hospitalier d' Auxerre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30784695 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atrial Fibrillation | D-dimer assay before ablation of atrial fibrillation D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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variables related to the presence of atrial thrombus
| 48 hours before ablation |
| Atrial Thrombus Exclusion (ATE) Score | The following thromboembolic risk factors mark 1 point if present in patient:
| 48 hours before ablation |
| 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 | 17019 | 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 | France |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atrial Fibrillation | D-dimer assay before ablation of atrial fibrillation D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Paroxysmal fibrillation | Count of Participants | Participants |
| |||||||||||||||||||||||
| Persistent fibrillation | Count of Participants | Participants |
| |||||||||||||||||||||||
| Left atrial tachycardia | Count of Participants | Participants |
| |||||||||||||||||||||||
| left ventricular ejection fraction | Mean | Standard Deviation | percentage of ejection fraction |
| ||||||||||||||||||||||
| Medical history | Count of Participants | Participants |
| |||||||||||||||||||||||
| Anticoagulation | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound | Posted | Count of Participants | Participants | up to 48 hours before ablation |
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| 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) | Posted | Count of Participants | Participants | 48 hours before ablation |
|
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| Secondary | Risk Factors | variables related to the presence of atrial thrombus | Posted | Count of Participants | Participants | 48 hours before ablation |
|
| ||||||||||||||||||||||||||||
| Secondary | Atrial Thrombus Exclusion (ATE) Score | The following thromboembolic risk factors mark 1 point if present in patient:
| Posted | Count of Participants | Participants | 48 hours before ablation |
|
|
Serious and non-serious adverse events (biological and clinical) that occured between the signature of the consent and the end of patient participation were reported. The duration of patient participation was 48 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atrial Fibrillation | D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement | 0 | 2,506 | 0 | 2,506 | 0 | 2,506 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Antoine Milhem | Groupe Hospitalier de la Rochelle Ré Aunis | +33546455050 | antoine.milhem@ch-larochelle.fr |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Diabetes mellitus |
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| Heart failure |
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| Stroke |
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| Venous thromboembolism |
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| Inflammatory disease |
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| Neoplasia |
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| Infectious disease |
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| Recent surgery |
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| RIVAROXABAN |
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| APIXABAN |
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| Effective Vitamin K antagonists |
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| Non effective Vitamin K antagonists |
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| Other |
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