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

What this Trial Is About

Transthyretin cardiac amyloidosis (ATTR-CA) is a heart condition where abnormal protein deposits affect the heart's structure and function. Early diagnosis is important to improve patient outcomes. This research evaluates an AI-powered ECG analysis platform called Willem17 to detect ATTR-CA by analyzing ECG data. The study aims to validate how well Willem17 can distinguish patients with confirmed ATTR-CA from those without the condition. The study is retrospective, observational, and involves multiple centers. It includes adults who either have a confirmed diagnosis of ATTR-CA or are suspected but later confirmed not to have ATTR-CA. Willem17 processes digital 12-lead ECG recordings of at least 10 seconds to identify cardiac patterns related to ATTR-CA. There are no treatments or interventions given since this is an observational study. Participants' existing ECG data will be analyzed to measure the device's performance in detecting ATTR-CA, including its ability to work with ECGs of varying quality. Researchers will compare Willem17 results with clinical diagnoses. The study monitors accuracy and reliability of the AI platform without affecting usual care. The total study duration extends until May 2026.

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