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

Idoven

Status

Not yet enrolling

Conditions

Transthyretin Cardiac Amyloidosis

Study type

Observational

Funder types

Industry

Identifiers

NCT06978660

CON_1b

Details and patient eligibility

About

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.

Full 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 Willem™ ECG Analysis platform has already shown its capability to process ECG data to detect cardiac patterns and arrythmias. This retrospective, observational, multicentric and single-arm study aims to expand the capabilities of the Willem™ ECG Analysis platform, in this case to detect ATTR-CA from ECG analysis.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria