Mode
Text Size
Log in / Sign up
N/A N=3,160

Exclusion of Intra-atrial Thrombus Before Catheter Ablation

Atrial Fibrillation · Thrombi

Enrolled (actual)
3,160
Serious AEs
0.1%
Results posted
Dec 2023
Primary outcome: Primary: Number of Patients With Atrial Thrombus and a Zero ATE Score — 2; 816; 27; 2227 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
ATE score (Diagnostic_test)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Primary completion
Nov 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Atrial Thrombus and a Zero ATE Score
2; 816; 27; 2227
SECONDARY
Number of Patients With Atrial Thrombus
29; 3043
SECONDARY
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score
3; 604; 26; 2438; 1
SECONDARY
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score
4; 1285; 25; 1757; 1

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03455673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search