Left Atrial Thrombus on Transesophageal Echocardiography

NCT ID: NCT03591627

Last Updated: 2018-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Atrial Flutter Transesophageal Echocardiography Ablation Cardioversion Thrombus; Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AF or AFl patients

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.

Transesophageal echocardiography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Transesophageal echocardiography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Agnieszka Kaplon-Cieslicka

Agnieszka Kapłoń-Cieślicka, Medical University of Warsaw

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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1st Department of Cariology of Medcial University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Agnieszka Kapłon-Cieślicka, PhD

Role: primary

+48 22 599 19 58

Other Identifiers

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1st Department of Cardiology

Identifier Type: -

Identifier Source: org_study_id

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