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Exclusion of Intra-atrial Thrombus Before Catheter Ablation

Completed
Conditions
Thrombi
Atrial 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
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Atrial fibrillationATE scoreATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
Primary Outcome Measures
NameTimeMethod
Number of Patients With Atrial Thrombus and a Zero ATE Scoreat 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
NameTimeMethod
Number of Patients With Atrial Thrombusat 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 Scoreat 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 Scoreat 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

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