Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
Idoven 1903 S.L.
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.
Description
Transthyretin cardiac amyloidosis (ATTR-CA) is an infiltrative cardiomyopathy affecting cardiac health. Results from clinical trials have shown the importance of early diagnosis to improve outcomes and maximize treatment efficacy. An electrocardiogram (ECG) is the most commonly performed cardiac diagnostic procedure, providing a large amount of information that can reflect cardiac structure and physiology. In this regard, ECG could be an ideal screening tool for ATTR-CA given its wide use, non-invasive nature, low cost and high sensitivity to reflect ATTR-CA abnormalities. The CE-marked Will…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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.
Locations (10)
- Northwestern UniversityEvanston, Illinois
- Centre Hospitalier Universitaire de ToulouseToulouse
- Universitätsklinikum BonnBonn
- L'Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-MalpighiBologna
- Careggi University HospitalFlorence
- United Hospitals of Trieste University HospitalTrieste