Atrial FibrillationLATTEENCT03591627
Left Atrial Thrombus on Transesophageal Echocardiography
An observational study of Atrial Fibrillation and Atrial Flutter, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Transesophageal Echocardiography
- What is being tested?
- Transesophageal echocardiography
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2018to 30 Sep 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
1st Department of Cariology of Medcial University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
Agnieszka Kapłon-Cieślicka, PhD, +48 22 599 19 58, agnieszka.kaplon@gmail.com
Agnieszka Kapłon-Cieślicka, PhD
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Transesophageal Echocardiography, Ablation, Cardioversion, Thrombus; Embolism
- Being tested
- Transesophageal echocardiography
- Keywords
- Atrial fibrillation, Atrial Flutter, Transesophageal echocardiography, Ablation, Cardioversion, Thrombus; Embolism
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal echocardiographyDiagnostic test
Transesophageal echocardiography will be used to exclude the presence of an LA thrombus before AF/AFI ablation or cardioversion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Transesophageal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the prevalence of LA thrombus in patients with AF/AFI, in whom TEE is performed before AF/AFl cardioversion or ablation.
Measured: One day
Secondary outcomes (3)
Comparison of the prevalence of LA thrombus in patients on different anticoagulant regimens.
Measured: Up to 12 months
Identification of the predictors of LA thrombus.
Measured: 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).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Kaplon-Cieslicka, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591627
- Sponsor's protocol ID
- 1st Department of Cardiology
- Acronym
- LATTEE
- Status last verified
- Nov 2018
- First submitted
- 7 Jul 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Thrombus on Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT03591627
- Acronym / sponsor ID
- LATTEE / 1st Department of Cardiology
- Conditions
- Atrial Fibrillation, Atrial Flutter, Transesophageal Echocardiography, Ablation, Cardioversion, Thrombus; Embolism
- Keywords
- Atrial fibrillation, Atrial Flutter, Transesophageal echocardiography, Ablation, Cardioversion, Thrombus; Embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF or AFl patients | – | Diagnostic Test: Transesophageal echocardiographyPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal echocardiographyTransesophageal echocardiography will be used to exclude the presence of an LA thrombus before AF/AFI ablation or cardioversion. | Diagnostic test | AF or AFl patients |
Primary outcome
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
3 secondary outcomes
Comparison of the prevalence of LA thrombus in patients on different anticoagulant regimens.
Time frame: Up to 12 months
Identification of the predictors of LA thrombus.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1st Department of Cariology of Medcial University of Warsaw
Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.