Exclusion of Intra-atrial Thrombus Before Catheter Ablation
- Conditions
- ThrombiAtrial Fibrillation
- Interventions
- Diagnostic Test: ATE score
- Registration Number
- NCT03455673
- Lead Sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3160
- Adult patients,
- Patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia,
- have signed or orally given an informed consent
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Atrial fibrillation ATE score ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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
Trial Locations
- Locations (15)
Service de cardiologie, Centre Hospitalier du pays d'Aix
🇫🇷Aix en Provence, France
Service de cardiologie, CHR Metz Thionville
🇫🇷Metz, France
Service de cardiologie, CHU Rouen
🇫🇷Rouen, 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
Hôpital Pitié Salpêtrière
🇫🇷Paris, France
Centre Hospitalier de Pau
🇫🇷Pau, France
Service de cardiologie, CHU Saint Etienne
🇫🇷Saint Etienne, France
Service de cardiologie, CHU Toulouse
🇫🇷Toulouse, France
Service de cardiologie, CH Annecy Genevois
🇫🇷Annecy, France
Service de cardiologie, Hôpital privé du Confluent
🇫🇷Nantes, France
Service de cardiologie, CHU Nîmes
🇫🇷Nîmes, France
University Hospital Geneva
🇨🇭Geneva, Switzerland
Service de cardiologie, Clinique Saint Joseph
🇫🇷Trélaze, France