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| Name | Class |
|---|---|
| Diagnostica Stago | INDUSTRY |
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Atrial fibrillation is the most frequent heart rhythm disorder. Its symptomatic forms, resistant to drug therapy, require invasive management (catheter ablation), which exposes to potentially serious complications including thromboembolic complications. Despite anticoagulant treatment, intra-atrial thrombus, which is a contraindication to catheter ablation, is detected in nearly 2 % of cases. Its diagnosis requires prior transoesophageal echocardiography, an unpleasant examination.
A previous study (NCT02199080) showed that a zero ATE score, defined by no heart failure, no hypertension, no history of stroke, d-dimer < 270 ng/mL, has a negative predictive value of 100 % for the exclusion of intra-atrial thrombus.
The objective of the study is to confirm the negative predictive value, sensitivity and specificity of the ATE score for the exclusion of intra-atrial thrombus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial fibrillation | ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATE score | Diagnostic Test | The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus : Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (> 270 ng/ml) = 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Atrial Thrombus and a Zero ATE Score | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, without hypertension, heart failure, history of stroke and a plasma d-dimer level < 270 ng/ml ATE : Atrial Thrombus Exclusion minimum value = 0 maximum value = 4, patient at higher risk of atrial thrombus | at most 48 hours before ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Atrial Thrombus | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal | at most 48 hours before ablation |
| Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score |
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Inclusion Criteria:
Exclusion Criteria:
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In each centre, patient eligible for atrial fibrillation or left flutter ablation will be screened. In agreement with the physician performing the procedure, the study will be explained and proposed to the eligible patients by an investigator at the admission or at the pre-ablation consultation. It is strongly recommended to include patients consecutively in order to limit selection bias.
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| Name | Affiliation | Role |
|---|---|---|
| Antoine MILHEM, MD | Groupe Hospitalier de la Rochelle Ré Aunis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de cardiologie, Centre Hospitalier du pays d'Aix | Aix-en-Provence | France | ||||
| Service de cardiologie, CH Annecy Genevois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30784695 | Background | 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. | |
| 11401607 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atrial Fibrillation | ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus : Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (> 270 ng/ml) = 1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atrial Fibrillation | ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus : Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (> 270 ng/ml) = 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 and a Zero ATE Score | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, without hypertension, heart failure, history of stroke and a plasma d-dimer level < 270 ng/ml ATE : Atrial Thrombus Exclusion minimum value = 0 maximum value = 4, patient at higher risk of atrial thrombus | Posted | Count of Participants | Participants | at most 48 hours before ablation |
|
The study lasted 48 hours for each participant. Adverse events were collected during these 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 | ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus : Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (> 270 ng/ml) = 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of consciousness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Allix-Béguec, manager of clinical trials | Groupe Hospitalier de la Rochelle Ré Aunis | +33546455050 | caroline.allix-beguec@ght-atlantique17.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2020 | Feb 17, 2023 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Peripheral blood sample is collected for d-dimer assay at the inclusion. Frozen samples will be used to constitute a plasma bank to further confirm the study performances with other D-dimer assays.
|
Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, and without congestive heart failure, hypertension, diabetes mellitus, vascular disease [previous myocardial infarction, peripheral arterial disease or aortic plaque], history of stroke or transient ischemic attack, aged under 75, and male minimum value = 0 maximum value = 10, at most risk of stroke
| at most 48 hours before ablation |
| Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, and without congestive heart failure, hypertension, diabetes mellitus, history of stroke or transient ischemic attack, and aged under 75 minimum value = 0 maximum value = 6, at most risk of stroke | at most 48 hours before ablation |
| Annecy |
| France |
| Service de cardiologie, CHU Brest | Brest | France |
| Groupe Hospitalier de la Rochelle Ré Aunis | La Rochelle | France |
| Service de cardiologie, CH Le Mans | Le Mans | France |
| Service de cardiologie, CHR Metz Thionville | Metz | France |
| Service de cardiologie, Hôpital privé du Confluent | Nantes | France |
| Service de cardiologie, CHU Nîmes | Nîmes | France |
| Hôpital Pitié Salpêtrière | Paris | France |
| Centre Hospitalier de Pau | Pau | France |
| Service de cardiologie, CHU Rouen | Rouen | France |
| Service de cardiologie, CHU Saint Etienne | Saint-Etienne | France |
| Service de cardiologie, CHU Toulouse | Toulouse | France |
| Service de cardiologie, Clinique Saint Joseph | Trélaze | France |
| University Hospital Geneva | Geneva | Switzerland |
| Background |
| Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001 Jun 13;285(22):2864-70. doi: 10.1001/jama.285.22.2864. |
| 32390061 | Background | Natale A, Mohanty S, Goldstein L, Gomez T, Hunter TD. Real-world safety of catheter ablation for atrial fibrillation with contact force or cryoballoon ablation. J Interv Card Electrophysiol. 2021 Apr;60(3):445-452. doi: 10.1007/s10840-020-00734-w. Epub 2020 May 11. |
| 28506916 | Background | Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available. |
| 19017348 | Background | Scherr D, Dalal D, Chilukuri K, Dong J, Spragg D, Henrikson CA, Nazarian S, Cheng A, Berger RD, Abraham TP, Calkins H, Marine JE. Incidence and predictors of left atrial thrombus prior to catheter ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2009 Apr;20(4):379-84. doi: 10.1111/j.1540-8167.2008.01336.x. Epub 2008 Oct 27. |
| 19926009 | Background | Puwanant S, Varr BC, Shrestha K, Hussain SK, Tang WH, Gabriel RS, Wazni OM, Bhargava M, Saliba WI, Thomas JD, Lindsay BD, Klein AL. Role of the CHADS2 score in the evaluation of thromboembolic risk in patients with atrial fibrillation undergoing transesophageal echocardiography before pulmonary vein isolation. J Am Coll Cardiol. 2009 Nov 24;54(22):2032-9. doi: 10.1016/j.jacc.2009.07.037. |
| 37804261 | Result | Milhem A, Anselme F, Da Costa A, Abbey S, Mansourati J, Bader H, Winum PF, Badenco N, Maury P, Dompnier A, Shah D, Johner N, Taieb J, Bertrand J, Treguer F, Amelot M, Ingrand P, Allix-Beguec C. ATE Score Diagnostic Accuracy for Predicting the Absence of Intra-Atrial Thrombi Before AF Ablation. JACC Clin Electrophysiol. 2023 Dec;9(12):2550-2557. doi: 10.1016/j.jacep.2023.08.019. Epub 2023 Oct 4. |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Clinical history of heart failure | Count of Participants | Participants |
|
| Clinical history of stroke or transient ischemic attack | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Vascular disease | Count of Participants | Participants |
|
| CHA2DS2VASc score | CHA2DS2VASc score is a stroke risk stratification scheme based on a risk factor approach Risk factors are quoted as follow:
Score range from 0 (lowest risk factor) to 10 (highest risk factor) | Median | Inter-Quartile Range | units on a scale |
|
| CHADS2 score | CHADS2 score is a stroke risk stratification scheme based on a risk factor approach Risk factors are quoted as follow:
Score range from 0 (lowest risk factor) to 5 (highest risk factor) | Median | Inter-Quartile Range | units on a scale |
|
| Diagnosis | Count of Participants | Participants |
|
|
|
| Secondary | Number of Patients With Atrial Thrombus | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal | Posted | Count of Participants | Participants | at most 48 hours before ablation |
|
|
|
| Secondary | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, and without congestive heart failure, hypertension, diabetes mellitus, vascular disease [previous myocardial infarction, peripheral arterial disease or aortic plaque], history of stroke or transient ischemic attack, aged under 75, and male minimum value = 0 maximum value = 10, at most risk of stroke | Posted | Count of Participants | Participants | at most 48 hours before ablation |
|
|
|
| Secondary | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, and without congestive heart failure, hypertension, diabetes mellitus, history of stroke or transient ischemic attack, and aged under 75 minimum value = 0 maximum value = 6, at most risk of stroke | Posted | Count of Participants | Participants | at most 48 hours before ablation |
|
|
|
| 0 |
| 3,072 |
| 2 |
| 3,072 |
| 1 |
| 3,072 |
| Hemorrhage | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| CHADS2VASC > 0, no thrombus |
|
| CHADS2VASC score unavailable |
|
| CHADS2 > 0, no thrombus |
|
| CHADS2 score unavailable |
|