An observational study in Atrial Fibrillation, sponsored by Atrial Fibrillation Network. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Atrial Fibrillation Network · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 600 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Atrial Fibrillation Network is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
European prospective cohort of patients with diagnosed AF.
Patients are distributed in 3 groups according to the different clinical manifestation of AF:
Exclusion Criteria:
200 patients
200 patients
200 patients
Physical examination
Weight (Kilograms-Kg) Height (centimeters-cm) Weight and height will be combined to calculate BMI in Kg/m\^2
Time frame: 12 months
Clinically relevant changes in CT/MRI
only if clinically indicated
Time frame: 12 months
Atrial Arrythmias (AA) burden and vascular stiffness (measured by a measuring bracelet)
AA burden and vascular stiffness measured by the measuring bracelet
Time frame: 12 months
Cognitive function test (MoCA)
evaluation of cognitive function (includes different tasks: visual/executive; naming; memory; attention; language; abstraction; delayed recall; orientation). Total score will be calculated and collected.
Time frame: Baseline and Follow up at 12 months
EQ-5D-5L Quality of Life questionnaire
quality of life assessment (includes questions about mobility, self care, usual activities, pain/discomfort and anxiety/depression). The health state code will be collected (calculated as concatenation of 5 scores). Health score from vertical visual analogue scale (0-100) will be collected.
Time frame: Baseline and Follow up at 12 months
Ischaemic events (systemic, myocardial and cerebral)
ischaemic events
Time frame: 12 months
Echo analysis (TEE_transesophageal echocardiography): LAA smoke available
collected as Yes/No
Time frame: 12 months
Echo analysis (TEE_transesophageal echocardiography): Flow velocity in LAA
measured in cm/sec
Time frame: 12 months
Echo analysis (TEE_transesophageal echocardiography): Antrum diameter
measured in mm
Time frame: 12 months
Echo analysis (TTE_transthoracic echocardiography): LVEF
Measured in %; Biplane Simpson Method
Time frame: 12 months
Echo analysis (TTE_transthoracic echocardiography): LA diameter
measured in mm LA volume (mL) Septum thickness (mm) Degree of mitral valve insufficiency (Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None). Degree of tricuspid valve insufficiency (Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None).
Time frame: 12 months
Echo analysis (TTE_transthoracic echocardiography): LA volume
measured in mL
Time frame: 12 months
Echo analysis (TTE_transthoracic echocardiography): Septum thickness
measured in mm Degree of mitral valve insufficiency (Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None). Degree of tricuspid valve insufficiency (Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None).
Time frame: 12 months
Echo analysis (TTE_transthoracic echocardiography): Degree of mitral valve insufficiency
Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None
Time frame: 12 months
Echo analysis (TTE_transthoracic echocardiography): Degree of tricuspid valve insufficiency
Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None
Time frame: 12 months
ECG analysis
Electrocardiogram analysis (paper and digital, if available). - 12-lead body surface ECG will be collected. Variables to be collected in the eCRF: Heart Rhythm (Sinus rhythm; Atrial Fibrillation; Continuous pacing; Pacing and AF; other (specify as free text). Heart rate (beats/min) Heart axis (degrees) QRS interval (msec) PR interval (msec) P-wave duration (msec) QT-duration (msec) QTcF (msec) Other relevant ECG findings (to add as free text).
Time frame: 12 months
MRI analysis: LAEF
Left atrial ejection fractio measured in %
Time frame: 12 months
MRI analysis: LAVi
LAVi left atrial volume index measured in ml/m\^2
Time frame: 12 months
MRI analysis: LALRS
LALRS left atrial longitudinal reservoir strain measured in %
Time frame: 12 months
MRI analysis: LALBS
LALBS left atrial longitudinal booster strain measured in %
Time frame: 12 months
CT scan analysis
The cardiac CTs will be sent to the specialised core lab for analysis. The analysis will include: Atriomic risk of stroke (5 year event risk) Yes/No
Time frame: 12 months
CT scan: Atriomic risk for AF
5 year event risk: Yes/No
Time frame: 12 months
CT scan: Epicardial Adipose tissue volume
measured in cm\^3
Time frame: 12 months
CT scan: Epicardial adipose tissue mean attenuation
measured in HU
Time frame: 12 months
CT scan: Left atrium volume
measured in cm\^3
Time frame: 12 months
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