Clinical trial NCT03591627: Left Atrial Thrombus on Transesophageal Echocardiography
Official title: Left Atrial Thrombus on Transesophageal Echocardiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Atrial Flutter
Transesophageal Echocardiography
Ablation
Cardioversion
Thrombus; Embolism
Keywords: Atrial fibrillation
Atrial Flutter
Transesophageal echocardiography
Ablation
Cardioversion
Thrombus; Embolism
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of the prevalence of LA thrombus in patients with AF/AFI, in whom TEE is performed before AF/AFl cardioversion or ablation.
timeFrame: One day
Secondary outcomes:
measure: Comparison of the prevalence of LA thrombus in patients on different anticoagulant regimens.
timeFrame: Up to 12 months
measure: Identification of the predictors of LA thrombus.
timeFrame: Up to 12 months
measure: 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).
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: 1st Department of Cariology of Medcial University of Warsaw
state: Mazowieckie
Study officials:
References: