Actively Recruiting

Age: 18Years +
All Genders
ID06584266

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Lack of informed, written consent to the transesophageal echocardiography

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Diagnostic Evaluation

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

Treatment

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)

Long-term Monitoring

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

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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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