Ireland
--:--IST
Recruiting Observational

Multimodal Cardiac Imaging Registry in Patients with Atrial Fibrillation

NCT06584266 · tracked via the Priya Life Science Poland tracker
Sponsor
University in Zielona Góra
Phase
Observational
Started
2024-01-01
Last updated
2024-09-04

Condition(s) studied

Atrial Fibrillation and FlutterHeart FailureArtificial Intelligence (AI)Echocardiography

Investigational drug(s) / intervention(s)

Transoesophageal echocardiographyCatheter ablation

Transoesophageal echocardiography: Imaging data obtained with transoesophageals echocardiography will be retained as well as data from transthoracic echocardiography and from other imaging modalities, if available

Catheter ablation: Cathether ablation of atrial fibrillation substrate using one of available methods.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 (all consecutive patients). Exclusion Criteria: Age\<18, lack of informed, written consent to the TEE

Primary outcome measure(s)

  • 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. — One day
    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).

Trial sites (7)

FacilityCityRegionStatus
St. Anne Hospital Brno Czechia Not Yet Recruiting
Nowa Sol Multidyscyplinary Hospital Nowa Sól Lubusz Voivodeship Recruiting
Medical University of Silesia Katowice Poland Not Yet Recruiting
John Paul II Hospital Krakow Poland Recruiting
Military Institute of Medicine National Research Institute Warsaw Poland Recruiting
National Institute of Cardiology Warsaw Poland Not Yet Recruiting
Collegium Medicum, University of Zielona Góra Zielona Góra Poland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06584266 on ClinicalTrials.gov ↗ ← All trials in Poland