Exclusion of Intra-atrial Thrombus Before Catheter Ablation

Atrial Fibrillation Clinical Trial

— EXTRALUCID  

Official title:

Diagnostic Accuracy of the ATE Score for the Exclusion of Intra-atrial Thrombi Before Catheter Ablation of Atrial Fibrillation: a Confirmatory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455673
• Other study ID #: 2017/P02/211
• Status: Completed
• Start date: September 18, 2018
• Est. completion date: November 7, 2020

Study information

• Verified date: December 2023
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3160
• Est. completion date: November 7, 2020
• Est. primary completion date: November 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients,
• Patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia,
• have signed or orally given an informed consent

Exclusion Criteria:

• Contraindication to transoesophageal echocardiography,
• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Thrombi
• Thrombosis

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
France	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
Switzerland	University Hospital Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis	Diagnostica Stago

Countries where clinical trial is conducted

France,  Switzerland, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	at most 48 hours before ablation
Secondary	Number of Patients With Atrial Thrombus	Patients with atrial thrombus diagnosed by pre-procedural transoesophageal	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	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	at most 48 hours before ablation