Exclusion of Intra-atrial Thrombus Before Catheter Ablation
NCT ID: NCT03455673
Last Updated: 2023-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
3160 participants
OBSERVATIONAL
2018-09-18
2020-11-07
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia,
* have signed or orally given an informed consent
Exclusion Criteria
* Transoesophageal echocardiography made in another centre than the centre of ablation,
* Pregnant women, parturient mothers and nursing mothers,
* Lives in an institution on court or authority order,
* Severely altered psychological health,
* Persons leaving in health or social establishment,
* Minors,
* Under guardianship,
* Persons unable to give their consent,
* Refusal to participate in the study.
18 Years
ALL
No
Sponsors
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Diagnostica Stago
INDUSTRY
Groupe Hospitalier de la Rochelle Ré Aunis
OTHER
Responsible Party
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Principal Investigators
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Antoine MILHEM, MD
Role: STUDY_DIRECTOR
Groupe Hospitalier de la Rochelle Ré Aunis
Locations
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Service de cardiologie, Centre Hospitalier du pays d'Aix
Aix-en-Provence, , France
Service de cardiologie, CH Annecy Genevois
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
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017/P02/211
Identifier Type: -
Identifier Source: org_study_id