Exclusion of Intra-atrial Thrombus Before Catheter Ablation

NCT03455673 | Completed Results

• 1 other identifier: 2017/P02/211
• Study Type: observational
• Target: 3,160
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Atrial Fibrillation; Thrombi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Patients With Atrial Thrombus

  at most 48 hours before ablation

• Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score

  at most 48 hours before ablation

• Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score

  at most 48 hours before ablation

Study Arms (1)

Atrial fibrillation

ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia

Diagnostic Test: ATE score

Interventions

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

Atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis: lead
• Diagnostica Stago: collaborator

Study Sites (15)

Service de cardiologie, Centre Hospitalier du pays d'Aix

Aix-en-Provence, France

Location

Service de cardiologie, CH Annecy Genevois

Annecy, France

Location

Service de cardiologie, CHU Brest

Brest, France

Location

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

Location

Service de cardiologie, CH Le Mans

Le Mans, France

Location

Service de cardiologie, CHR Metz Thionville

Metz, France

Location

Service de cardiologie, Hôpital privé du Confluent

Nantes, France

Location

Service de cardiologie, CHU Nîmes

Nîmes, France

Location

Hôpital Pitié Salpêtrière

Paris, France

Location

Centre Hospitalier de Pau

Pau, France

Location

Service de cardiologie, CHU Rouen

Rouen, France

Location

Service de cardiologie, CHU Saint Etienne

Saint-Etienne, France

Location

Service de cardiologie, CHU Toulouse

Toulouse, France

Location

Service de cardiologie, Clinique Saint Joseph

Trélaze, France

Location

University Hospital Geneva

Geneva, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 30784695 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.

  PMID: 11401607 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.

  PMID: 32390061 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.

  PMID: 28506916 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.

  PMID: 19017348 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.

  PMID: 19926009 BACKGROUND

• 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.

  PMID: 37804261 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Atrial Fibrillation; Thrombosis

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Results Point of Contact

• Title: Caroline Allix-Béguec, manager of clinical trials
• Organization: Groupe Hospitalier de la Rochelle Ré Aunis

caroline.allix-beguec@ght-atlantique17.fr

+33546455050

Study Officials

• Antoine MILHEM, MD

  Groupe Hospitalier de la Rochelle Ré Aunis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 6, 2018
• Study Start: September 18, 2018
• Primary Completion: November 7, 2020
• Study Completion: November 7, 2020
• Last Updated: March 19, 2026
• Results First Posted: December 22, 2023

Record last verified: 2026-03

Locations

FR (14); CH (1)