RecruitingNCT06978660

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

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


Sponsor

Idoven 1903 S.L.

Enrollment

2,000 participants

Start Date

May 27, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria1

  • Patients with paced rhythm on the ECG.

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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

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NCT06978660


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