Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloid
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 b
| Condition(s) | Transthyretin Cardiac Amyloidosis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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). Thus, this study will assess Willem™ ability to distinguish between truly diagnosed ATTR-CA patients and confirmed non-ATTR-CA patients from ECG data. |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Idoven 1903 S.L. |
| Locations | Evanston, Illinois, United States; Toulouse, France; Bonn, Germany; Bologna, Italy; Florence, Italy; Trieste, Italy (+4 more sites) |
| Start date | 2025-05-27 |
| NCT ID | NCT06978660 |
| Official listing | https://clinicaltrials.gov/study/NCT06978660 |