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Recruiting NCT06978660
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
Trial Parameters
Condition Transthyretin Cardiac Amyloidosis
Sponsor Idoven 1903 S.L.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-05-27
Completion 2026-05
Brief 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.
Eligibility 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.