Clinical trial NCT03455673: Exclusion of Intra-atrial Thrombus Before Catheter Ablation
Official title: Diagnostic Accuracy of the ATE Score for the Exclusion of Intra-atrial Thrombi Before Catheter Ablation of Atrial Fibrillation: a Confirmatory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Thrombi
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
Collaborators: name: Diagnostica Stago
First posted: 2018-03-06
Enrollment: 3160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Atrial Thrombus and a Zero ATE Score
timeFrame: at most 48 hours before ablation
Secondary outcomes:
measure: Number of Patients With Atrial Thrombus
timeFrame: at most 48 hours before ablation
measure: Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score
timeFrame: at most 48 hours before ablation
measure: Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score
timeFrame: at most 48 hours before ablation
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Service de cardiologie, Centre Hospitalier du pays d'Aix
city: Annecy
country: France
facility: Service de cardiologie, CH Annecy Genevois
city: Brest
country: France
facility: Service de cardiologie, CHU Brest
city: La Rochelle
country: France
facility: Groupe Hospitalier de la Rochelle Ré Aunis
city: Le Mans
country: France
facility: Service de cardiologie, CH Le Mans
city: Metz
country: France
facility: Service de cardiologie, CHR Metz Thionville
city: Nantes
country: France
facility: Service de cardiologie, Hôpital privé du Confluent
city: Nîmes
country: France
facility: Service de cardiologie, CHU Nîmes
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Rouen
country: France
facility: Service de cardiologie, CHU Rouen
city: Saint Etienne
country: France
facility: Service de cardiologie, CHU Saint Etienne
city: Toulouse
country: France
facility: Service de cardiologie, CHU Toulouse
city: Trélaze
country: France
facility: Service de cardiologie, Clinique Saint Joseph
city: Geneva
country: Switzerland
facility: University Hospital Geneva
Study officials:
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Antoine MILHEM, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.
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.
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.