Clinical Trial

Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis

Study acronym: CONCERTO
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
notable Enrollment increased: 2000 -> 2200 participants 2026-06-24
notable Primary completion pushed: 2026-05 -> 2026-09-30 2026-06-24
minor Completion pushed: 2026-05 -> 2026-12-31 2026-06-24
Trial Details
NCT Number NCT06978660
Lead Sponsor Idoven 1903 S.L.
Collaborators: AstraZeneca
Conditions Transthyretin Cardiac Amyloidosis
Enrollment 2,200 participants
Start Date 2025-05-27
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-20