Left Atrial Thrombus on Transesophageal Echocardiography

• Conditions: Cardioversion; Transesophageal Echocardiography; Thrombus; Embolism; Ablation; Atrial Fibrillation; Atrial Flutter
• Interventions: Diagnostic Test: Transesophageal echocardiography

• Registration Number: NCT03591627
• Lead Sponsor: Medical University of Warsaw

Brief Summary

The aim of the study is to assess the prevalence of left atrial thrombus in patients with atrial fibrillation (AF) or atrial flutter (AFI), in whom transesophageal echocardiography is performed before AF/AFl cardioversion or ablation.

Detailed Description

Atrial fibrillation (AF) and atrial flutter (AFI) increase the risk of thromboembolic events by promoting clot formation in the left atrium (LA). Transesophageal echocardiography (TEE) is routinely used to exclude the presence of an LA thrombus before AF/AFI ablation or cardioversion. So far, it has not been established what is the optimal combination of noninvasive parameters for thromboembolic risk stratification in this setting. The present study is aimed to compare the prevalence of LA thrombus in patients on different anticoagulant regimens, identify predictors of LA thrombus and validate the newly developed CHA2DS2-VASc-AF-GFR score (and to compare its predictive value in LA thrombus identification with those of the CHA2DS2-VASc and the CHADS2 scores).

The study protocol all patients with AF or AFl in whom TEE will be performed (to assess their eligibility for cardioversion or ablation), hospitalized in a participating center during study period.

Study Timeline

• Study First Submitted: 2018-07-07
• Study First Submitted QC: 2018-07-07
• Study First Posted: 2018-07-19
• Study Start: 2018-10-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-05
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• All patients with AF or AFl in whom TEE will be performed (to assess their eligibility for cardioversion or ablation), hospitalized in a participating center during study period.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AF or AFl patients	Transesophageal echocardiography	Patients with AF or AFl in whom TEE will be performed (to assess their eligibility for cardioversion or ablation), hospitalized in a participating center during study period.

Primary Outcome Measures

Name	Time	Method
Assessment of the prevalence of LA thrombus in patients with AF/AFI, in whom TEE is performed before AF/AFl cardioversion or ablation.	One day

Secondary Outcome Measures

Name	Time	Method
Comparison of the prevalence of LA thrombus in patients on different anticoagulant regimens.	Up to 12 months
Identification of the predictors of LA thrombus.	Up to 12 months
Validation of the the newly developed CHA2DS2-VASc-AF-GFR score (and to compare its predictive value in LA thrombus identification with those of the CHA2DS2-VASc and the CHADS2 scores).	Up to 12 months

Trial Locations

Locations (1)

1st Department of Cariology of Medcial University of Warsaw; 🇵🇱 Warsaw, Mazowieckie, Poland