Validation of the AI-Powered Willem ECG Platform to Detect Transthyretin Cardiac Amyloidosis in Adults

What this Trial Is About

This research aims to validate the Willem electrocardiogram ECG analysis platform, an AI-powered and cloud-based tool, for detecting Transthyretin cardiac amyloidosis ATTR-CA. ATTR-CA is a heart condition caused by protein buildup affecting cardiac structure and function. Early diagnosis is important to improve treatment outcomes, and this study evaluates the platforms ability to differentiate confirmed ATTR-CA patients from those without the condition using ECG data. The study is retrospective, observational, and involves multiple centers. It includes adult patients confirmed with ATTR-CA and adults suspected of having ATTR-CA but ultimately diagnosed without it. Willem analyzes 12-lead ECG recordings of at least 10 seconds duration to detect cardiac patterns associated with ATTR-CA. This single-arm study focuses on assessing the devices performance in identifying ATTR-CA from ECG information. Participants ECG data are reviewed and compared to confirm diagnosis status. The primary measurement is device performance at baseline, corresponding to the closest clinical assessment to ATTR-CA diagnosis. The study also evaluates device performance using ECGs with suboptimal data quality. The trial begins in May 2025 and completes by December 2026, with no interventions or treatments provided to participants as it is observational.

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