Exclusion of Intra-atrial Thrombus Before Catheter Ablation

Groupe Hospitalier de la Rochelle Ré Aunis3,160 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

3,160

Conditions

Atrial Fibrillation Thrombi

Interventions

ATE scoreDIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

Service de cardiologie, Centre Hospitalier du pays d'Aix

Aix-en-Provence, France

Service de cardiologie, CH Annecy Genevois

Annecy, France

Service de cardiologie, CHU Brest

Brest, France

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

Service de cardiologie, CH Le Mans

Le Mans, France

Service de cardiologie, CHR Metz Thionville

Metz, France

Service de cardiologie, Hôpital privé du Confluent

Nantes, France

Service de cardiologie, CHU Nîmes

Nîmes, France

Hôpital Pitié Salpêtrière

Paris, France

Centre Hospitalier de Pau

Pau, France

...and 5 more locations

Outcomes

Primary Outcomes

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

Secondary Outcomes

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