N/A N=2,506 Diagnostic

D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT02199080 ↗

Enrolled (actual)

2,506

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound — 48 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: D-dimer assay before ablation of atrial fibrillation (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound	48	—
SECONDARY CHADS2 Score	5; 1277; 20; 744; 13; 299	—
SECONDARY Risk Factors	8; 148; 15; 661; 28; 968	—
SECONDARY Atrial Thrombus Exclusion (ATE) Score	0; 911; 23; 965; 14; 467	—

Summary

The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of intraatrial thrombus before performing an ablation of atrial fibrillation

Eligibility Criteria

Inclusion Criteria

Age> 18 years.
Patients hospitalized for ablation of atrial fibrillation or symptomatic left flutter
Patient informed of the study

Exclusion Criteria

Age <18 years.
Patients under guardianship
Pregnant woman
Contraindication to transesophageal echocardiography
transesophageal echocardiography made in another center as the center of ablation
Refusal of the patient to participate in the study
Patient participating in another interventional study in which an intervention related to biomedical research is performed before the transesophageal echocardiography

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02199080). 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.