IMAGE-AF
Multimodal, Multicentre Registry of Clinical and Imaging Data to Develop Predictive Models Based on Artificial Intelligence to Support the Diagnostic and Therapeutic Process for Patients with Atrial Fibrillation Undergoing Catheter Ablation and Cardioversion.
Sponsor study identifier
observational
3,000
2 countries
7
Study Start
January 1, 2024
Actual (reported)Primary Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2024
Actual (reported)August 31, 2024
Actual (reported)September 4, 2024
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
One day
Follow up for adverse outcomes
1 year
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.
Imaging data obtained with transoesophageals echocardiography will be retained as well as data from transthoracic echocardiography and from other imaging modalities, if available
Cathether ablation of atrial fibrillation substrate using one of available methods.
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.
St. Anne Hospital
Brno, Czechia
Nowa Sol Multidyscyplinary Hospital
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Medical University of Silesia
Konrad Pieszko, MD, PhD
University of Zielona Gora
First Submitted
August 31, 2024
First Posted
September 4, 2024
Study Start
January 1, 2024
Actual (reported)Primary Completion
September 2026
Estimated (date passed)Prognostic Factors for Ablation of Atrial Fibrillation
Follow up for ablation recurrence
1 year
Electroanatomical data
One Day
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Katowice, Poland
John Paul II Hospital
Krakow, Poland
Military Institute of Medicine National Research Institute
Warsaw, Poland
National Institute of Cardiology
Warsaw, Poland
Collegium Medicum, University of Zielona Góra
Zielona Góra, Poland
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 4, 2024
Record last verified: 2024-08
We plan to release an anonymized dataset in a public repository at the end of the study. This is depending on data sharing agreements with individual sites so the final dataset may not include all participating sites or all variables.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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