N/A
Completed N=3,160
Exclusion of Intra-atrial Thrombus Before Catheter Ablation
Atrial Fibrillation · Thrombi
Source: ClinicalTrials.gov NCT03455673 ↗
Enrolled (actual)
3,160
Serious AEs
0.1%
Results posted
Dec 2023
Primary outcomePrimary: Number of Patients With Atrial Thrombus and a Zero ATE Score — 2; 816; 27; 2227 Participants
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.
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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. Informational only — not medical advice.