Clinical Cohorts for Validation of New Digital Biomarkers (MAESTRIA)

Atrial Fibrillation Network (AFNET)

Status

Enrolling

Conditions

Atrial Fibrillation

Study type

Observational

Funder types

Other

Identifiers

NCT05855538

MAESTRIA-AFNET10

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.