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

Recruiting now

Conditions studied: Transthyretin Cardiac Amyloidosis

In brief

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.

Key facts

Study ID

NCT06978660

Run by

Idoven 1903 S.L.

People needed

2200

Starts

2025-05-27

Expected to finish

2026-12-31

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects ≥ 18 years old
• Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format

You may not qualify if…

• Patients with paced rhythm on the ECG.

Where it is running

• Queen Elizabeth University Hospital, Univeisity of Glasgow — Glasgow, United Kingdom (enrolling)
• Centre Hospitalier Universitaire de Toulouse — Toulouse, France (enrolling)
• Hospital Universitario Son Llàtzer — Palma de Mallorca, Balearic Islands, Spain (enrolling)
• TUM Klinikum Deutsches Herzzentrum — München, Germany
• Northwestern University — Evanston, Illinois, United States
• Hospital Universitario Donostia — San Sebastián, Guipúzcoa, Spain
• Hospital Universitario Juan Ramón Jiménez — Huelva, Huelva, Spain
• Universitätsklinikum Bonn — Bonn, Germany

Full record on ClinicalTrials.gov

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