Validation of new digital biomarkers for Atrial Fibrillation
Machine Learning and Artificial Intelligence for Early Detection of Stroke and Atrial Fibrillation. Clinical Cohorts for Validation of New Digital Biomarkers
This study is testing new digital tools to help doctors better diagnose and treat different types of Atrial Fibrillation in patients across Europe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Atrial Fibrillation Network Academic / other |
| Locations | 1 site (Paderborn) |
| Trial ID | NCT05855538 on ClinicalTrials.gov |
What this trial studies
The MAESTRIA study is an international observational registry aimed at enrolling a diverse group of European patients diagnosed with Atrial Fibrillation (AF). It focuses on analyzing clinical parameters, including digitalized ECGs, echocardiograms, cardiac CTs, MRIs, and blood biomarkers, to develop diagnostic tools for atrial cardiomyopathy. Patients will be categorized into three groups based on the type of AF they have: paroxysmal, persistent, or permanent. The study aims to create multi-parametric digital tools that integrate AI processing and big data to enhance the diagnosis and treatment of AF and related conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with paroxysmal, persistent, or permanent Atrial Fibrillation.
Not a fit: Patients with a life expectancy of less than one year or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and personalized therapies for patients with Atrial Fibrillation.
How similar studies have performed: Other studies have shown promise in developing digital biomarkers and AI tools for cardiovascular conditions, indicating a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with paroxysmal AF, persistent AF or permanent AF. * Patients (or legally acceptable representative if applicable to country specific regulations) provide written informed consent to participate in the study. The patient has the option to give separate consent to donate extra volume of blood during the routine blood collection, that can be used for biomedical research. * Patient is at least 18 years old. * Patient must own a smartphone with Apple iOS version 14.5 (or higher) or with Android version 8.0 (or higher). Exclusion Criteria: * Any disease that limits life expectancy to less than 1 year. * All persons unable to provide informed consent. * All persons exempt from participation in a study or trial by law. * Any medical or psychiatric condition which, in the investigator´s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
Where this trial is running
Paderborn
- St Vincenz Hospital — Paderborn, Germany (Recruiting)
Study contacts
- Study coordinator: Andreas Götte, Prof
- Email: Andreas.Goette@vincenz.de
- Phone: +49 05251/86-1651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.