AI-powered ECG tool to detect transthyretin cardiac amyloidosis early.
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
Idoven 1903 S.L. · NCT06978660
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Idoven 1903 S.L. (industry) |
| Locations | 10 sites (Evanston, Illinois and 9 other locations) |
| Trial ID | NCT06978660 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Evanston, Illinois and 9 other locations
- Northwestern University — Evanston, Illinois, United States (RECRUITING)
- Centre Hospitalier Universitaire de Toulouse — Toulouse, France (RECRUITING)
- Universitätsklinikum Bonn — Bonn, Germany (RECRUITING)
- L'Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi — Bologna, Italy (NOT_YET_RECRUITING)
- Careggi University Hospital — Florence, Italy (NOT_YET_RECRUITING)
- United Hospitals of Trieste University Hospital — Trieste, Italy (NOT_YET_RECRUITING)
- Hospital Universitario Son Llàtzer — Palma de Mallorca, Balearic Islands, Spain (RECRUITING)
- Hospital Universitario Donostia — San Sebastián, Guipúzcoa, Spain (RECRUITING)
- Hospital Universitario Juan Ramón Jiménez — Huelva, Huelva, Spain (RECRUITING)
- Queen Elizabeth University Hospital, Univeisity of Glasgow — Glasgow, United Kingdom (NOT_YET_RECRUITING)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Transthyretin Cardiac Amyloidosis, Transthyretin cardiac amyloidosis, ATTR, AI-based ECG Analysis