Health Trials

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

ConditionTransthyretin Cardiac Amyloidosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIdoven 1903 S.L.

About this trial

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 criteria

Qualifiers

Subjects ≥ 18 years old

Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format

Disqualifiers

Patients with paced rhythm on the ECG.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

2,200 Participants
are grouped into 2 trial groups

Locations

8
France
Centre Hospitalier Universitaire de Toulouse31300, Toulouse France
Germany
Universitätsklinikum Bonn53127, Bonn Germany
TUM Klinikum Deutsches Herzzentrum80636, München Germany
Spain
Hospital Universitario Son Llàtzer07198, Palma de MallorcaBalearic Islands, Spain

Sponsors and collaborators

Idoven 1903 S.L.

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov