NCT03591627

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

12 months

First QC Date

July 7, 2018

Last Update Submit

November 2, 2018

Conditions

Atrial FibrillationAtrial FlutterTransesophageal EchocardiographyAblationCardioversionThrombus; Embolism

Keywords

Atrial fibrillationAtrial FlutterTransesophageal echocardiographyAblationCardioversionThrombus; Embolism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

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

Interventions

Transesophageal echocardiographyDIAGNOSTIC_TEST

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

AF or AFl patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Department of Cariology of Medcial University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationAtrial FlutterThromboembolism

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular Diseases

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Agnieszka Kapłoń-Cieślicka, Medical University of Warsaw

Study Record Dates

First Submitted

July 7, 2018

First Posted

July 19, 2018

Study Start

October 1, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

November 5, 2018

Record last verified: 2018-11

Locations

PL(1)