Actively Recruiting

Age: 18Years +
All Genders
NCT06978660

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

Led by Idoven 1903 S.L. · Updated on 2026-03-16

2000

Participants Needed

10

Research Sites

48 weeks

Total Duration

On this page

Sponsors

I

Idoven 1903 S.L.

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects 63; 18 years old
  • Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format
Not Eligible

You will not qualify if you...

  • Patients with paced rhythm on the ECG.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Northwestern University

Evanston, Illinois, United States, 60208

Actively Recruiting

2

Centre Hospitalier Universitaire de Toulouse

Toulouse, France, 31300

Actively Recruiting

3

Universitätsklinikum Bonn

Bonn, Germany, 53127

Actively Recruiting

4

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

Bologna, Italy, 40138

Not Yet Recruiting

5

Careggi University Hospital

Florence, Italy, 50134

Not Yet Recruiting

6

United Hospitals of Trieste University Hospital

Trieste, Italy, 34128

Not Yet Recruiting

7

Hospital Universitario Son Llàtzer

Palma de Mallorca, Balearic Islands, Spain, 07198

Actively Recruiting

8

Hospital Universitario Donostia

San Sebastián, Guipúzcoa, Spain, 20014

Actively Recruiting

9

Hospital Universitario Juan Ramón Jiménez

Huelva, Huelva, Spain, 21005

Actively Recruiting

10

Queen Elizabeth University Hospital, Univeisity of Glasgow

Glasgow, United Kingdom, G51 4TF

Not Yet Recruiting

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Research Team

M

Manuel Marina-Breysse, MSc, MD

CONTACT

J

José María Lillo, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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