Left Atrial Thrombus on Transesophageal Echocardiography (LATTEE)

November 2, 2018 updated by: Agnieszka Kaplon-Cieslicka, Medical University of Warsaw
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-097
        • Recruiting
        • 1st Department of Cariology of Medcial University of Warsaw
        • Contact:
        • Principal Investigator:
          • Agnieszka Kapłon-Cieślicka, PhD
        • Sub-Investigator:
          • Monika Gawałko, MD
        • Sub-Investigator:
          • Monika Budnik, PhD
        • Sub-Investigator:
          • Iwona Gorczyca, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Transesophageal echocardiography
Transesophageal echocardiography will be used to exclude the presence of an LA thrombus before AF/AFI ablation or cardioversion.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of the prevalence of LA thrombus in patients on different anticoagulant regimens.
Time Frame: Up to 12 months
Up to 12 months
Identification of the predictors of LA thrombus.
Time Frame: Up to 12 months
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).
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

July 7, 2018

First Submitted That Met QC Criteria

July 7, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1st Department of Cardiology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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