Multimodal Cardiac Imaging Registry in Patients with Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity in Zielona Góra
About this trial
The goal of this observational registry is to collect a curated dataset of multimodal imaging data that will serve for development of artificial-intelligence based solutions for prediction of risk and outcomes in patients with atrial fribrillation.
Type of study: observational study
Study Participants: Patients with atrial fibrillation or atrial flutter who undergo clinically indicated transesophageal echocardiography before catheter ablation or cardioversion.
We hypothesize, that automatic analysis of video images of transthoracic echocardiography with deep learning combined with clinical data can predict the presence of left atrial appendage thrombus (LAT). Therefore, our main aim is to create and validate an artificial intelligence model to predict the presence of LAT based on automatic analysis of transthoracic echocardiography with artificial intelligence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Transoesophageal echocardiography
Diagnostic testImaging data obtained with transoesophageals echocardiography will be retained as well as data from transthoracic echocardiography and from other imaging modalities, if available
Catheter ablation
Procedure/SurgeryCathether ablation of atrial fibrillation substrate using one of available methods.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: AF or AFl patients2 interventions
Trial outcomes
Primary outcomes
1
Assessment of the presence of left atrial appendage thrombus in patients with atrial fibrillation or atrial flutter, in whom tranesophageal is performed before cardioversion or catheter ablation ablation.
We will asses the left atrial appendage in transesophageal echocardiography (TEEO for the presence of the left atrial appendage thrombus. During TEE we will record multiple projections of the left atrial appendage and we will measure laeft atrial appendage flows as listed below: 1. Projection on LAA (Left Atrial Appendage): 0, 45, 90, 135 degrees, and other projections that are necessary to correctly image the entire LAA according to the investigator/ echocardiographer. 2. 3D acquisition of the volume that contains LAA (multi-beat-optimized). 3. Measurement of maximum emptying velocity of LAA 1cm from the LAA ostium - at least three measurements in two different scanning angles, averaged. 4. Acquisition of spectral Doppler image of LAA emptying (three images from two or more scanning angles) (still images).
Time frame
One daySecondary outcomes
1
Follow up for adverse outcomes
Follow-up for death, stroke, myocardial infarction, new onset or worsening of heart failure or acute limb ischemia. This will be obtained trough telephone interview.
Time frame
1 year2
Follow up for ablation recurrence
If possible, we will follow up the patients for AF recurrence.
Time frame
1 yearOther outcomes
1
Electroanatomical data
In patients who undergo catheter ablation with elepctroanatomical mapping we will collect and analyze data acquired during the procedure.
Time frame
One DaySponsors and contacts
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University in Zielona Góra
Lead sponsor
Military Institute od Medicine National Research Institute
Collaborator
National Institute of Cardiology, Warsaw, Poland
Collaborator
Medical University of Silesia, Katowice, Poland
Collaborator
St. Anne's University Hospital Brno, Czech Republic
Collaborator
John Paul II Hospital, Krakow
Collaborator
Nowa Sol Multidyscyplinary Hospital, Poland
Collaborator
Source ClinicalTrials.gov