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RECRUITING
NCT06978660

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

Sponsor: Idoven 1903 S.L.

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.

Official title: Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2025-05-27

Completion Date

2026-05

Last Updated

2026-03-16

Healthy Volunteers

No

Locations (10)

Northwestern University

Evanston, Illinois, United States

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Universitätsklinikum Bonn

Bonn, Germany

L'Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

Bologna, Italy

Careggi University Hospital

Florence, Italy

United Hospitals of Trieste University Hospital

Trieste, Italy

Hospital Universitario Son Llàtzer

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Donostia

San Sebastián, Guipúzcoa, Spain

Hospital Universitario Juan Ramón Jiménez

Huelva, Huelva, Spain

Queen Elizabeth University Hospital, Univeisity of Glasgow

Glasgow, United Kingdom