Transthyretin Cardiac AmyloidosisCONCERTONCT06978660
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
An observational study of Transthyretin Cardiac Amyloidosis, run by Idoven 1903 S.L. at 8 sites in 5 countries.
Trial summary
CONCERTO is a retrospective, observational, multicentric and single-arm study to perform an external validation of the cloud-based and AI-powered electrocardiogram (ECG) analysis platform, named Willem™, to detect Transthyretin cardiac amyloidosis (ATTR-CA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Cardiac Amyloidosis
- How many people
- 2,200 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 27 May 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subjects with a suspected or confirmed diagnosis of ATTR-CA
Who may be able to join
- Subjects ≥ 18 years old
- Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format
Who cannot join
- Patients with paced rhythm on the ECG.
Trial locations and contacts
8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
José María Lillo, PhD contact
8 sites in 5 countries
Spain3 sites, 1 recruiting
- Completed
Hospital Universitario Juan Ramón Jiménez
Huelva, Huelva, 21005
- Recruiting
Hospital Universitario Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Tomás Ripoll Vera, MD, PhD
Tomás Ripoll Vera, MD, PhD
- Completed
Hospital Universitario Donostia
San Sebastián, Guipúzcoa, 20014
Germany2 sites, 1 recruiting
- Completed
Universitätsklinikum Bonn
Bonn, 53127
- Not yet recruiting
TUM Klinikum Deutsches Herzzentrum
München, 80636
Moritz von Scheidt, MD, PhD
Moritz von Scheidt, MD, PhD
United States1 site
- Completed
Northwestern University
Evanston, Illinois, 60208
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Toulouse
Toulouse, 31300
Olivier Lairez, MD, PhD
Olivier Lairez, MD, PhD
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital, Univeisity of Glasgow
Glasgow, G51 4TF
David Lowe, MD, MSc
David Lowe, MD, MSc
About this study
Official title: Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
CONCERTO is a retrospective, observational, multicentric and single-arm study to perform an external validation of the cloud-based and AI-powered electrocardiogram (ECG) analysis platform, named Willem™, to detect Transthyretin cardiac amyloidosis (ATTR-CA). Thus, this study will assess Willem™ ability to distinguish between truly diagnosed ATTR-CA patients and confirmed non-ATTR-CA patients from ECG data.
Read the detailed description
Transthyretin cardiac amyloidosis (ATTR-CA) is an infiltrative cardiomyopathy affecting cardiac health. Results from clinical trials have shown the importance of early diagnosis to improve outcomes and maximize treatment efficacy.
An electrocardiogram (ECG) is the most commonly performed cardiac diagnostic procedure, providing a large amount of information that can reflect cardiac structure and physiology. In this regard, ECG could be an ideal screening tool for ATTR-CA given its wide use, non-invasive nature, low cost and high sensitivity to reflect ATTR-CA abnormalities.
The CE-marked Willem™ ECG Analysis platform has already shown its capability to process ECG data to detect cardiac patterns and arrythmias. This retrospective, observational, multicentric and single-arm study aims to expand the capabilities of the Willem™ ECG Analysis platform, in this case to detect ATTR-CA from ECG analysis.
- Conditions
- Transthyretin Cardiac Amyloidosis
- Keywords
- Transthyretin cardiac amyloidosis, ATTR, AI-based ECG Analysis
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 |
|---|---|---|
| ATTR-CA patients | Adult patients with confirmed diagnosis of ATTR-CA | |
| Controls (non ATTR-CA subjects) | Adult subjects suspected of ATTR-CA, but finally confirmed not to have ATTR-CA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device performance
Assessment of Willem ability to distinguish between confirmed diagnosed ATTR-CA patients and subjects with no ATTR-CA diagnosis from ECG data of sufficient quality.
The diagnostic performance metrics will be accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score.
Measured: Baseline (closest clinical assessment to ATTR-CA diagnosis)
Secondary outcomes (1)
Device performance with sub-optimal ECG data quality
Assessment of Willem ability to distinguish between confirmed diagnosed ATTR-CA patients and subjects with no ATTR-CA diagnosis from ECG data which does not meet the minimum pre-specified quality requirements.
The diagnostic performance metrics will be accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score.
Measured: Baseline (closest clinical assessment to ATTR-CA diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start27 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Cardiac AmyloidosisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Idoven 1903 S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Pablo García Pavía, MD, PhD, Principal investigator, Hospital Universitario Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978660
- Sponsor's protocol ID
- CON_1b
- Acronym
- CONCERTO
- Status last verified
- Jul 2026
- First submitted
- 9 May 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
- ClinicalTrials.gov ID
- NCT06978660
- Acronym / sponsor ID
- CONCERTO / CON_1b
- Conditions
- Transthyretin Cardiac Amyloidosis
- Keywords
- Transthyretin cardiac amyloidosis, ATTR, AI-based ECG Analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Idoven 1903 S.L.Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 27 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 May 2025 (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.
CONCERTO is a retrospective, observational, multicentric and single-arm study to perform an external validation of the cloud-based and AI-powered electrocardiogram (ECG) analysis platform, named Willem™, to detect Transthyretin cardiac amyloidosis (ATTR-CA). Thus, this study will assess Willem™ ability to distinguish between truly diagnosed ATTR-CA patients and confirmed non-ATTR-CA patients from ECG data.
Detailed description
Transthyretin cardiac amyloidosis (ATTR-CA) is an infiltrative cardiomyopathy affecting cardiac health. Results from clinical trials have shown the importance of early diagnosis to improve outcomes and maximize treatment efficacy.
An electrocardiogram (ECG) is the most commonly performed cardiac diagnostic procedure, providing a large amount of information that can reflect cardiac structure and physiology. In this regard, ECG could be an ideal screening tool for ATTR-CA given its wide use, non-invasive nature, low cost and high sensitivity to reflect ATTR-CA abnormalities.
The CE-marked Willem™ ECG Analysis platform has already shown its capability to process ECG data to detect cardiac patterns and arrythmias. This retrospective, observational, multicentric and single-arm study aims to expand the capabilities of the Willem™ ECG Analysis platform, in this case to detect ATTR-CA from ECG analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATTR-CA patients | – | –Adult patients with confirmed diagnosis of ATTR-CA |
| Controls (non ATTR-CA subjects) | – | –Adult subjects suspected of ATTR-CA, but finally confirmed not to have ATTR-CA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a suspected or confirmed diagnosis of ATTR-CA
Key inclusion criteria (2 listed)
- Subjects ≥ 18 years old
- Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format
Key exclusion criteria (1 listed)
- Patients with paced rhythm on the ECG.
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
Device performance
Time frame: Baseline (closest clinical assessment to ATTR-CA diagnosis)
Assessment of Willem ability to distinguish between confirmed diagnosed ATTR-CA patients and subjects with no ATTR-CA diagnosis from ECG data of sufficient quality. The diagnostic performance metrics will be accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score.
1 secondary outcome
Device performance with sub-optimal ECG data quality
Time frame: Baseline (closest clinical assessment to ATTR-CA diagnosis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Transthyretin Cardiac Amyloidosis
Not yet recruitingObservational study
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Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Not yet recruitingPhase 2
Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
Transthyretin Cardiac Amyloidosis
Not yet recruitingObservational study
PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels
Amyloidogenic Transthyretin (ATTR) Amyloidosis, Cardiac Amyloidosis
Active, not recruitingPhase 3
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Transthyretin Amyloid Cardiomyopathy
Enrolling by invitationPhase 3
A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
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.
José María Lillo, PhD contact
Pablo García Pavía, MD, PhD principal investigator
Hospital Universitario Puerta de Hierro
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transthyretin Cardiac Amyloidosis, run by Idoven 1903 S.L. at 8 sites in 5 countries.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Germany, United States, France, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuel Marina-Breysse, MSc, MD (+34618103160, m@idoven.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device performance (time frame: Baseline (closest clinical assessment to ATTR-CA diagnosis)). 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 20 Jul 2026.