Atrial FibrillationMAESTRIANCT05855538
Clinical Cohorts for Validation of New Digital Biomarkers
An observational study of Atrial Fibrillation and Atrial Cardiomyopathy, run by Atrial Fibrillation Network at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Cardiomyopathy
- How many people
- 515 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2023to 31 Aug 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: European prospective cohort of patients with diagnosed AF. Patients are distributed in 3 groups according to the different clinical manifestation of AF: 1. Patients with paroxysmal AF (clinically defined as AF episodes less than one week), or 2. Patients with persistent AF (clinically defined as AF episodes longer than one week), or 3. Patients with permanent AF (no documented sinus rhythm or possibility to restore sinus rhythm by any means)
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Machine Learning and Artificial Intelligence for Early Detection of Stroke and Atrial Fibrillation. Clinical Cohorts for Validation of New Digital Biomarkers
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.
Read the detailed 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.
- Conditions
- Atrial Fibrillation, Atrial Cardiomyopathy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal AF | 215 patients | |
| Persistent AF | 216 patients | |
| Permanent AF | 84 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical examination
Weight (Kilograms-Kg) Height (centimeters-cm) Weight and height will be combined to calculate BMI in Kg/m^2
Measured: 12 months
Clinically relevant changes in CT/MRI
only if clinically indicated
Measured: 12 months
Atrial Arrythmias (AA) burden and vascular stiffness (measured by a measuring bracelet)
AA burden and vascular stiffness measured by the measuring bracelet
Measured: 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.
Measured: 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.
Measured: Baseline and Follow up at 12 months
Ischaemic events (systemic, myocardial and cerebral)
ischaemic events
Measured: 12 months
Echo analysis (TEE_transesophageal echocardiography): LAA smoke available
collected as Yes/No
Measured: 12 months
Echo analysis (TEE_transesophageal echocardiography): Flow velocity in LAA
measured in cm/sec
Measured: 12 months
Echo analysis (TEE_transesophageal echocardiography): Antrum diameter
measured in mm
Measured: 12 months
Echo analysis (TTE_transthoracic echocardiography): LVEF
Measured in %; Biplane Simpson Method
Measured: 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).
Measured: 12 months
Echo analysis (TTE_transthoracic echocardiography): LA volume
measured in mL
Measured: 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).
Measured: 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
Measured: 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
Measured: 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).
Measured: 12 months
MRI analysis: LAEF
Left atrial ejection fractio measured in %
Measured: 12 months
MRI analysis: LAVi
LAVi left atrial volume index measured in ml/m^2
Measured: 12 months
MRI analysis: LALRS
LALRS left atrial longitudinal reservoir strain measured in %
Measured: 12 months
MRI analysis: LALBS
LALBS left atrial longitudinal booster strain measured in %
Measured: 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
Measured: 12 months
Secondary outcomes (4)
CT scan: Atriomic risk for AF
5 year event risk: Yes/No
Measured: 12 months
CT scan: Epicardial Adipose tissue volume
measured in cm^3
Measured: 12 months
CT scan: Epicardial adipose tissue mean attenuation
measured in HU
Measured: 12 months
CT scan: Left atrium volume
measured in cm^3
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start2 Mar 2023
- Primary completion24 Jul 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 515 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Atrial Fibrillation Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Hatem, Prof, Study director, ICAN Nutrition Education and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855538
- Sponsor's protocol ID
- MAESTRIA-AFNET10
- Acronym
- MAESTRIA
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning and Artificial Intelligence for Early Detection of Stroke and Atrial Fibrillation. Clinical Cohorts for Validation of New Digital Biomarkers
- ClinicalTrials.gov ID
- NCT05855538
- Acronym / sponsor ID
- MAESTRIA / MAESTRIA-AFNET10
- Conditions
- Atrial Fibrillation, Atrial Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Atrial Fibrillation NetworkUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal AF | – | –215 patients |
| Persistent AF | – | –216 patients |
| Permanent AF | – | –84 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- European prospective cohort of patients with diagnosed AF. Patients are distributed in 3 groups according to the different clinical manifestation of AF: 1. Patients with paroxysmal AF (clinically defined as AF episodes less than one week), or 2. Patients with persistent AF (clinically defined as AF episodes longer than one week), or 3. Patients with permanent AF (no documented sinus rhythm or possibility to restore sinus rhythm by any means)
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical examination
Time frame: 12 months
Weight (Kilograms-Kg) Height (centimeters-cm) Weight and height will be combined to calculate BMI in Kg/m^2
Clinically relevant changes in CT/MRI
Time frame: 12 months
only if clinically indicated
Atrial Arrythmias (AA) burden and vascular stiffness (measured by a measuring bracelet)
Time frame: 12 months
AA burden and vascular stiffness measured by the measuring bracelet
Cognitive function test (MoCA)
Time frame: Baseline and Follow up at 12 months
evaluation of cognitive function (includes different tasks: visual/executive; naming; memory; attention; language; abstraction; delayed recall; orientation). Total score will be calculated and collected.
EQ-5D-5L Quality of Life questionnaire
Time frame: Baseline and Follow up at 12 months
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.
Ischaemic events (systemic, myocardial and cerebral)
Time frame: 12 months
ischaemic events
Echo analysis (TEE_transesophageal echocardiography): LAA smoke available
Time frame: 12 months
collected as Yes/No
Echo analysis (TEE_transesophageal echocardiography): Flow velocity in LAA
Time frame: 12 months
measured in cm/sec
Echo analysis (TEE_transesophageal echocardiography): Antrum diameter
Time frame: 12 months
measured in mm
Echo analysis (TTE_transthoracic echocardiography): LVEF
Time frame: 12 months
Measured in %; Biplane Simpson Method
Echo analysis (TTE_transthoracic echocardiography): LA diameter
Time frame: 12 months
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).
Echo analysis (TTE_transthoracic echocardiography): LA volume
Time frame: 12 months
measured in mL
Echo analysis (TTE_transthoracic echocardiography): Septum thickness
Time frame: 12 months
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).
Echo analysis (TTE_transthoracic echocardiography): Degree of mitral valve insufficiency
Time frame: 12 months
Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None
Echo analysis (TTE_transthoracic echocardiography): Degree of tricuspid valve insufficiency
Time frame: 12 months
Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None
ECG analysis
Time frame: 12 months
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).
MRI analysis: LAEF
Time frame: 12 months
Left atrial ejection fractio measured in %
MRI analysis: LAVi
Time frame: 12 months
LAVi left atrial volume index measured in ml/m^2
MRI analysis: LALRS
Time frame: 12 months
LALRS left atrial longitudinal reservoir strain measured in %
MRI analysis: LALBS
Time frame: 12 months
LALBS left atrial longitudinal booster strain measured in %
CT scan analysis
Time frame: 12 months
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
4 secondary outcomes
CT scan: Atriomic risk for AF
Time frame: 12 months
CT scan: Epicardial Adipose tissue volume
Time frame: 12 months
CT scan: Epicardial adipose tissue mean attenuation
Time frame: 12 months
CT scan: Left atrium volume
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Hatem, Prof study director
ICAN Nutrition Education and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Cardiomyopathy, run by Atrial Fibrillation Network at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical examination (time frame: 12 months). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.