Clinical Cohorts for Validation of New Digital Biomarkers

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT05855538

MAESTRIA-AFNET10

Ages > 18
All Genders

Study Summary

The MAESTRIA study is an international, multi-centre, non-interventional, observational registry. The main goal is to enrol a representative group of European patients diagnosed with Atrial Fibrillation (AF) to analyse clinical and relevant parameters (digitalised ECG, echocardiograms, cardiac CTs, MRIs and blood biomarkers) that could be used during clinical practise for the diagnosis of atrial cardiomyopathy. The AF patients will be distributed in 3 groups according to the different manifestation of AF: paroxysmal, persistent and permanent AF.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with paroxysmal AF, persistent AF or permanent AF.
Patients (or legally acceptable representative if applicable to country specificregulations) provide written informed consent to participate in the study. The patienthas the option to give separate consent to donate extra volume of blood during theroutine 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 Androidversion 8.0 (or higher).

Exclusion

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, wouldpreclude the participant from adhering to the protocol or completing the study perprotocol.

Study Design

March 02, 2023

August 31, 2025

Study Description

Atrial fibrillation (AF) and stroke are major health care problems in Europe. They are most often the clinical expression of atrial cardiomyopathy, which is under-recognised due to the lack of specific diagnostic tools. Multidisciplinary research and stratified approaches are urgently needed to prevent, diagnose, and treat AF and stroke and preempt the AF-related threat to healthy ageing in Europe.

MAESTRIA is a European consortium of 18 clinicians, scientists and pharma industry partners who are at the forefront of research and medical care of AF and stroke patients funded by the EU Horizon 2020 programme (grant number 965286). The Atrial Fibrillation Network (AFNET) is one of the 18 partner institutions in this European consortium.

MAESTRIA will create multi-parametric digital tools based on a new generation of biomarkers that integrate artificial intelligence (AI) processing and big data from cutting edge imaging, electrocardiography and omics technologies. It will develop novel biomarkers, diagnostic tools and personalized therapies for atrial cardiomyopathy.

The MAESTRIA-AFNET 10 Study is an integral part of the MAESTRIA project. The study will collect relevant clinical parameters for AF from patients, this includes ECGs, cardiac CTs, MRIs and echocardiograms. Dedicated core labs will collect and homogenize the clinical data.

For atrial arrhythmias (AA) and vascular stiffness index (VSI) recording, patients will be provided with a measuring bracelet for continuous monitoring of heart rhythm with a photoplethysmographic (PPG) sensor coupled with a smartphone app and the Preventicus Heartbeats® analytic service (Class IIa, CE marked), approved as consumer device. Preventicus is ISO 13485 certified.

Connect with a study center

St Vincenz Hospital
Paderborn, 33098
Germany
Active - Recruiting

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