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

NCT06978660 · tracked via the Priya Life Science Germany tracker

Sponsor

Idoven 1903 S.L

Phase

Observational

Started

2025-05-27

Last updated

2026-07-20

Condition(s) studied

Transthyretin Cardiac Amyloidosis

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Device performance — Baseline (closest clinical assessment to ATTR-CA diagnosis)
Assessment of Willem ability to distinguish between confirmed diagnosed ATTR-CA patients and subjects with no ATTR-CA diagnosis from ECG data of sufficient quality. The diagnostic performance metrics will be accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score.

Trial sites (8)

Facility	City	Region	Status
Northwestern University	Evanston	Illinois	Completed
Centre Hospitalier Universitaire de Toulouse	Toulouse	France	Recruiting
Universitätsklinikum Bonn	Bonn	Germany	Completed
TUM Klinikum Deutsches Herzzentrum	München	Germany	Not Yet Recruiting
Hospital Universitario Son Llàtzer	Palma de Mallorca	Balearic Islands	Recruiting
Hospital Universitario Donostia	San Sebastián	Guipúzcoa	Completed
Hospital Universitario Juan Ramón Jiménez	Huelva	Huelva	Completed
Queen Elizabeth University Hospital, Univeisity of Glasgow	Glasgow	United Kingdom	Recruiting

More Idoven 1903 S.L. trials in Germany

Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06978660 on ClinicalTrials.gov ↗ ← All trials in Germany