Atrial FibrillationEXTRALUCIDNCT03455673
Exclusion of Intra-atrial Thrombus Before Catheter Ablation
An observational study of Atrial Fibrillation and Thrombi, run by Groupe Hospitalier de la Rochelle Ré Aunis at 15 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Thrombi
- What is being tested?
- ATE score
- How many people
- 3,160 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 18 Sep 2018to 7 Nov 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients,
- Patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia,
- have signed or orally given an informed consent
Who cannot join
- 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,
Show all 10Show fewer
- Minors,
- Under guardianship,
- Persons unable to give their consent,
- Refusal to participate in the study.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
France14 sites
Service de cardiologie, Centre Hospitalier du pays d'Aix
Aix-en-Provence
Service de cardiologie, CH Annecy Genevois
Annecy
Service de cardiologie, CHU Brest
Brest
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle
Service de cardiologie, CH Le Mans
Le Mans
Service de cardiologie, CHR Metz Thionville
Metz
Service de cardiologie, Hôpital privé du Confluent
Nantes
Service de cardiologie, CHU Nîmes
Nîmes
Hôpital Pitié Salpêtrière
Paris
Centre Hospitalier de Pau
Pau
Service de cardiologie, CHU Rouen
Rouen
Service de cardiologie, CHU Saint Etienne
Saint-Etienne
Service de cardiologie, CHU Toulouse
Toulouse
Service de cardiologie, Clinique Saint Joseph
Trélaze
About this study
Official title: Diagnostic Accuracy of the ATE Score for the Exclusion of Intra-atrial Thrombi Before Catheter Ablation of Atrial Fibrillation: a Confirmatory Study
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
- Being tested
- ATE score
- Medical subject headings
- Atrial Fibrillation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATE scoreDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation | ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia Receives: Diagnostic Test: ATE score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at most 48 hours before ablation
Secondary outcomes (3)
Number of Patients With Atrial Thrombus
Patients with atrial thrombus diagnosed by pre-procedural transoesophageal
Measured: at most 48 hours before ablation
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
Measured: 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
Measured: at most 48 hours before ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start18 Sep 2018
- Primary completion7 Nov 2020
- Study completion7 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Collaborators
- Diagnostica Stago
- Responsible party
- Sponsor
- Investigators
- Antoine MILHEM, MD, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455673
- Sponsor's protocol ID
- 2017/P02/211
- Acronym
- EXTRALUCID
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2018
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30784695Gage 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.
PubMed 11401607Natale 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.
PubMed 32390061Calkins 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.
PubMed 28506916Scherr 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.
PubMed 19017348Puwanant 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.
PubMed 19926009Milhem 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.
PubMed 37804261
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the ATE Score for the Exclusion of Intra-atrial Thrombi Before Catheter Ablation of Atrial Fibrillation: a Confirmatory Study
- ClinicalTrials.gov ID
- NCT03455673
- Acronym / sponsor ID
- EXTRALUCID / 2017/P02/211
- Conditions
- Atrial Fibrillation, Thrombi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,160 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Collaborators
- Diagnostica Stago
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 7 Nov 2020 (actual)
- Study completion
- 7 Nov 2020 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Posted 22 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation | – | Diagnostic Test: ATE scoreATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult patients,
- Patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia,
- have signed or orally given an informed consent
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATE scoreThe 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 | Diagnostic test | Atrial fibrillation |
Primary outcome
Number of Patients With Atrial Thrombus and a Zero ATE Score
Time frame: at most 48 hours before ablation
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
3 secondary outcomes
Number of Patients With Atrial Thrombus
Time frame: at most 48 hours before ablation
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score
Time frame: at most 48 hours before ablation
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score
Time frame: at most 48 hours before ablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30784695Milhem 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.
- Background: PubMed 11401607Gage 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.
- Background: PubMed 32390061Natale 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.
- Background: PubMed 28506916Calkins 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.
- Background: PubMed 19017348Scherr 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.
- Background: PubMed 19926009Puwanant 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.
- Results publication: PubMed 37804261Milhem 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine MILHEM, MD study director
Groupe Hospitalier de la Rochelle Ré Aunis
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Thrombi, run by Groupe Hospitalier de la Rochelle Ré Aunis at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Atrial Thrombus and a Zero ATE Score (time frame: at most 48 hours before ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03455673, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.