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.
Subjects ≥ 18 years old
Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format
Patients with paced rhythm on the ECG.
Subjects with a suspected or confirmed diagnosis of ATTR-CA
Case-control
Retrospective
Not listed
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.
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.
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Idoven 1903 S.L.
Lead sponsor
AstraZeneca
Collaborator
