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Clinical Trials in Spain / NCT06978660
Recruiting Observational

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

NCT06978660 · tracked via the Priya Life Science Spain 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
No
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)

FacilityCityRegionStatus
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 Spain

Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION) Recruiting
Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform Recruiting
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM) 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 Spain