Atrial Fibrillation, Thrombi
Conditions
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.
Interventions
DIAGNOSTIC_TESTATE 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
Sponsors
Groupe Hospitalier de la Rochelle Ré Aunis
Diagnostica Stago
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Atrial Thrombus and a Zero ATE Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Atrial Thrombus | at most 48 hours before ablation | Patients with atrial thrombus diagnosed by pre-procedural transoesophageal |
| Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score | at most 48 hours before ablation | 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 |
| Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score | at most 48 hours before ablation | 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 |
Countries
France, Switzerland
Contacts
STUDY_DIRECTORAntoine MILHEM, MD
Groupe Hospitalier de la Rochelle Ré Aunis
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atrial Fibrillation ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
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 | 3,072 |
| Total | 3,072 |
Baseline characteristics
| Characteristic | Atrial Fibrillation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1650 Participants |
| Age, Categorical Between 18 and 65 years | 1422 Participants |
| Age, Continuous | 66 years |
| CHA2DS2VASc score | 2 units on a scale |
| CHADS2 score | 1 units on a scale |
| Clinical history of heart failure | 459 Participants |
| Clinical history of stroke or transient ischemic attack | 175 Participants |
| Diabetes mellitus | 350 Participants |
| Diagnosis Left atrial tachycardia | 308 Participants |
| Diagnosis Paroxysmal fibrillation | 1638 Participants |
| Diagnosis Persistent fibrillation | 1126 Participants |
| Hypertension | 1292 Participants |
| Region of Enrollment France | 2996 participants |
| Region of Enrollment Switzerland | 76 participants |
| Sex: Female, Male Female | 863 Participants |
| Sex: Female, Male Male | 2209 Participants |
| Vascular disease | 376 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3,072 |
| other Total, other adverse events | 1 / 3,072 |
| serious Total, serious adverse events | 2 / 3,072 |
Outcome results
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
Time frame: at most 48 hours before ablation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atrial Fibrillation | Number of Patients With Atrial Thrombus and a Zero ATE Score | ATE = 0, thrombus | 2 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus and a Zero ATE Score | ATE = 0, No thrombus | 816 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus and a Zero ATE Score | ATE > 0, thrombus | 27 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus and a Zero ATE Score | ATE > 0, No thrombus | 2227 Participants |
Secondary
Number of Patients With Atrial Thrombus
Patients with atrial thrombus diagnosed by pre-procedural transoesophageal
Time frame: at most 48 hours before ablation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atrial Fibrillation | Number of Patients With Atrial Thrombus | Thrombus diagnosed by the reference method | 29 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus | No thrombus diagnosed by the reference method | 3043 Participants |
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
Time frame: at most 48 hours before ablation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score | CHADS2 = 0, thrombus | 4 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score | CHADS2 = 0, no thrombus | 1285 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score | CHADS2 > 0, thrombus | 25 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score | CHADS2 > 0, no thrombus | 1757 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score | CHADS2 score unavailable | 1 Participants |
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
Time frame: at most 48 hours before ablation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score | CHADS2VASC = 0, thrombus | 3 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score | CHADS2VASC = 0, no thrombus | 604 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score | CHADS2VASC > 0, thrombus | 26 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score | CHADS2VASC > 0, no thrombus | 2438 Participants |
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score | CHADS2VASC score unavailable | 1 Participants |