Left Atrial Thrombus on Transesophageal Echocardiography

Atrial Fibrillation Clinical Trial

— LATTEE  

Official title:

Left Atrial Thrombus on Transesophageal Echocardiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03591627
• Other study ID #: 1st Department of Cardiology
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2018
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ablation
• Atrial Fibrillation
• Atrial Flutter
• Cardioversion
• Embolism
• Thromboembolism
• Thrombosis
• Thrombus; Embolism
• Transesophageal Echocardiography

Intervention

Diagnostic Test:
• Transesophageal echocardiography
Transesophageal echocardiography will be used to exclude the presence of an LA thrombus before AF/AFI ablation or cardioversion.

Locations

Country	Name	City	State
Poland	1st Department of Cariology of Medcial University of Warsaw	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of the prevalence of LA thrombus in patients on different anticoagulant regimens.		Up to 12 months
Secondary	Identification of the predictors of LA thrombus.		Up to 12 months
Secondary	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