Actively Recruiting
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
Led by University in Zielona Góra · Updated on 2024-09-04
3000
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University in Zielona Góra
Lead Sponsor
M
Military Institute od Medicine National Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting detailed imaging and clinical data from patients with atrial fibrillation or atrial flutter who undergo transesophageal echocardiography to better understand and predict the risks associated with left atrial appendage thrombus (LAT). This observational study aims to develop artificial intelligence models that analyze transthoracic echocardiography images and clinical information to predict the presence of LAT, which is linked to stroke risk and complicates cardioversion or catheter ablation procedures. The study involves gathering multimodal imaging data including transesophageal echocardiography, transthoracic echocardiography, cardiac CT, cardiac magnetic resonance, and electrocardiograms, both retrospectively and prospectively. Patients undergo clinically indicated transesophageal echocardiography before catheter ablation or cardioversion. Optional imaging modalities and clinical data are collected to form a comprehensive database that supports AI-based model development and validation. Participants will have their imaging data and clinical records collected during hospitalization, with follow-up data on adverse outcomes and atrial fibrillation recurrence tracked for up to one year. Researchers will assess the presence of left atrial appendage thrombus using these data, aiming to improve diagnostic and therapeutic approaches. The study involves no treatment administration but focuses on detailed imaging acquisition and clinical monitoring to support artificial intelligence research.
CONDITIONS
Brief Title
Multimodal Cardiac Imaging Registry in Patients with Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients with atrial fibrillation or atrial flutter who will have transesophageal echocardiography to assess eligibility for cardioversion or ablation during hospitalization in a participating center
You will not qualify if you...
- Age under 18 years
- Lack of informed, written consent to the transesophageal echocardiography
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 3 days around the hospitalization for cardioversion or catheter ablation
Participants undergo transoesophageal echocardiography, transthoracic echocardiography, and other imaging modalities to assess the presence of left atrial appendage thrombus and support diagnostic and therapeutic decisions.
1 to 2 visits depending on procedures performed
Duration - Varies by participant based on clinical treatment
Participants undergo catheter ablation of atrial fibrillation using available methods as part of their clinical care.
1 catheter ablation procedure visit (in-person)
Duration - Up to 1 year post-treatment
Participants are followed for up to 1 year to monitor for adverse outcomes including mortality, stroke, and recurrence of atrial fibrillation after treatment.
Follow-up visits and/or telephone interviews as per local availability
Trial Site Locations
Total: 7 locations
1
St. Anne Hospital
Brno, Czechia
Not Yet Recruiting
2
Nowa Sol Multidyscyplinary Hospital
Nowa Sól, Lubusz Voivodeship, Poland, 67-100
Actively Recruiting
3
Medical University of Silesia
Katowice, Poland
Not Yet Recruiting
4
John Paul II Hospital
Krakow, Poland
Actively Recruiting
5
Military Institute of Medicine National Research Institute
Warsaw, Poland
Actively Recruiting
6
National Institute of Cardiology
Warsaw, Poland
Not Yet Recruiting
7
Collegium Medicum, University of Zielona Góra
Zielona Góra, Poland
Actively Recruiting
Research Team
K
Konrad Pieszko, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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