An observational study in Atrial Fibrillation and Thrombi, sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Completed at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Observational
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.
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.
Exclusion Criteria:
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
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
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
Time frame: at most 48 hours before ablation
Number of Patients With Atrial Thrombus
Patients with atrial thrombus diagnosed by pre-procedural transoesophageal
Time frame: 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
Time frame: 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
Time frame: at most 48 hours before ablation
| Milestone | Atrial Fibrillation |
|---|---|
| Started | 3160 |
| Patients with an ate score | 3099 |
| Completed | 3072 |
| Not completed | 88 |
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
| Participants | Atrial Fibrillation |
|---|---|
| ATE = 0, thrombus | 2 |
| ATE = 0, No thrombus | 816 |
| ATE > 0, thrombus | 27 |
| ATE > 0, No thrombus | 2227 |
Patients with atrial thrombus diagnosed by pre-procedural transoesophageal
| Participants | Atrial Fibrillation |
|---|---|
| Thrombus diagnosed by the reference method | 29 |
| No thrombus diagnosed by the reference method | 3043 |
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
| Participants | Atrial Fibrillation |
|---|---|
| CHADS2VASC = 0, thrombus | 3 |
| CHADS2VASC = 0, no thrombus | 604 |
| CHADS2VASC > 0, thrombus | 26 |
| CHADS2VASC > 0, no thrombus | 2438 |
| CHADS2VASC score unavailable | 1 |
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
| Participants | Atrial Fibrillation |
|---|---|
| CHADS2 = 0, thrombus | 4 |
| CHADS2 = 0, no thrombus | 1285 |
| CHADS2 > 0, thrombus | 25 |
| CHADS2 > 0, no thrombus | 1757 |
| CHADS2 score unavailable | 1 |
Collected over The study lasted 48 hours for each participant. Adverse events were collected during these 48 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atrial Fibrillation | 0/3,072 (0%) | 2/3,072 (0.1%) | 1/3,072 (0%) |
| Event | Atrial Fibrillation |
|---|---|
| PericarditisCardiac disorders | 1/3072 |
| HemorrhageBlood and lymphatic system disorders | 1/3072 |
| Event | Atrial Fibrillation |
|---|---|
| Loss of consciousnessNervous system disorders | 1/3072 |
| Age, Categorical(Participants) | Atrial Fibrillation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1422 |
| >=65 years | 1650 |
| Age, Continuous(years) | Atrial Fibrillation |
|---|---|
| Median | 66 (58 to 71) |
| Sex: Female, Male(Participants) | Atrial Fibrillation |
|---|---|
| Female | 863 |
| Male | 2209 |
| Race and Ethnicity Not Collected(Participants) | Atrial Fibrillation |
|---|
| Region of Enrollment(participants) | Atrial Fibrillation |
|---|---|
| France | 2996 |
| Switzerland | 76 |
| Clinical history of heart failure(Participants) | Atrial Fibrillation |
|---|---|
| Count of participants | 459 |
| Clinical history of stroke or transient ischemic attack(Participants) | Atrial Fibrillation |
|---|---|
| Count of participants | 175 |
| Hypertension(Participants) | Atrial Fibrillation |
|---|---|
| Count of participants | 1292 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
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Groupe Hospitalier de la Rochelle Ré Aunis