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

RECRUITINGSponsored by Idoven 1903 S.L.
Actively Recruiting
SponsorIdoven 1903 S.L.
Started2025-05-27
Est. completion2026-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

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

Exclusion Criteria:

* Patients with paced rhythm on the ECG.

Conditions2

Heart DiseaseTransthyretin Cardiac Amyloidosis

Locations1 site

Northwestern University
Evanston, Illinois, 60208
Faraz Ahmad, MD, MS

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