AI-powered ECG tool to detect transthyretin cardiac amyloidosis early.
Official title: Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
Run by Idoven 1903 S.L. · NCT06978660 · Data updated 2026-11-12
This project will test whether the Willem™ AI ECG platform can tell people with transthyretin cardiac amyloidosis from those without using routine 12‑lead digital ECG recordings.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2200 (estimated) |
| Sponsor | Idoven 1903 S.L. Industry-sponsored |
| Locations | 8 sites (Evanston, Illinois and 7 other locations) |
| Status | Recruiting |
| Started | May 27, 2025 |
| Main results expected | December 2026 |
| Study ends | January 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT06978660 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who have a digital 12‑lead ECG recording of at least 10 seconds and no paced rhythm, whether they have confirmed ATTR‑CA or are confirmed non‑ATTR‑CA, are the intended candidates.
✕Probably not a fit
People with paced cardiac rhythms, non‑digital or shorter ECG recordings, or younger than 18 are unlikely to benefit from this validation effort.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a retrospective, observational, multicenter external validation of the cloud-based Willem™ AI ECG analysis platform to detect transthyretin cardiac amyloidosis (ATTR‑CA). The study uses digital 12‑lead ECGs of at least 10 seconds from patients with confirmed ATTR‑CA and confirmed non‑ATTR‑CA to measure the algorithm's diagnostic performance. Patients with paced rhythms on ECG are excluded, and data are pooled across participating centers in the US and Europe. Willem™ is CE‑marked and has shown capability to detect other cardiac patterns and arrhythmias, and this study aims to expand and validate its use for ATTR‑CA detection.
Why it matters
Potential benefit: If successful, this could provide a simple, noninvasive way to flag people for earlier confirmatory testing and treatment for ATTR‑CA.
How similar studies have gone: Prior AI‑ECG research and some commercial tools have shown promise detecting cardiac conditions including features of amyloidosis, and Willem™ has demonstrated accuracy for other ECG patterns, but external validation specifically for ATTR‑CA remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects ≥ 18 years old * Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format Exclusion Criteria: * Patients with paced rhythm on the ECG.
Where it's running
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Centre Hospitalier Universitaire de Toulouse
Toulouse, France Recruiting -
Hospital Universitario Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain Recruiting -
Queen Elizabeth University Hospital, Univeisity of Glasgow
Glasgow, United Kingdom Recruiting -
Northwestern University
Evanston, Illinois, United States Completed -
Universitätsklinikum Bonn
Bonn, Germany Completed -
TUM Klinikum Deutsches Herzzentrum
München, Germany Not yet recruiting
Show 2 more locations
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Hospital Universitario Donostia
San Sebastián, Guipúzcoa, Spain Completed -
Hospital Universitario Juan Ramón Jiménez
Huelva, Huelva, Spain Completed
Study contacts
- Principal investigator: Pablo García Pavía, MD, PhD — Hospital Universitario Puerta de Hierro
- Study coordinator: Manuel Marina-Breysse, MSc, MD
- Email: m@idoven.ai
- Phone: +34618103160
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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68Ga-FAPI-46 PET imaging to stage ATTR-CM and spot progression
This study tests whether a gallium-68 labeled FAPI PET scan can help stage transthyretin cardiac amyloidosis and identify patients whose disease is progressing.
-
Personalized exercise program for patients with transthyretin cardiac amyloidosis
This study is testing a personalized exercise program to see if it can help people with transthyretin cardiac amyloidosis feel stronger and improve their quality of life.
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Liver and Coagulation Markers in ATTR Cardiac Amyloidosis
This study tests liver function and blood-clotting markers in people with ATTR-CA to see if they reflect disease severity and progression.
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Acoramidis to slow progression of transthyretin cardiac amyloidosis
This trial will test whether acoramidis slows disease progression in people with transthyretin cardiac amyloidosis who are either newly starting treatment or switching from tafamidis.
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Acoramidis for ATTR-CM: Cardiac Imaging Study
This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.
-
Long-term safety of eplontersen in adults with transthyretin amyloidosis, including those with prior liver transplant or severe liver impairment
This study will see if eplontersen remains safe over time for adults with transthyretin amyloidosis, including people who have had a liver transplant or have severe liver problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.