Validating Willem™ for Early Cardiac Amyloidosis Diagnosis
This study is testing an artificial intelligence (AI) platform called Willem™ that analyzes electrocardiogram (ECG) data to help detect Transthyretin Cardiac Amyloidosis (ATTR-CA). ATTR-CA is a heart condition where abnormal proteins build up in the heart. The goal is to see how well Willem™ can identify ATTR-CA in people who have already been diagnosed, using their existing ECG records. Early diagnosis of ATTR-CA is important for better treatment outcomes. This study is looking for people aged 18 and older who have 12-lead ECG records at least 10 seconds long in a digital format. You cannot participate if your ECG shows a paced rhythm. The main goal is to see how accurately Willem™ performs in identifying ATTR-CA.
- Study design
- This is an observational study, meaning it looks at existing data rather than giving new treatments. It is a single-arm study, planning to include 2200 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, device performance, is measured at baseline, which is the closest clinical assessment to ATTR-CA diagnosis.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
At a glance
Conditions
NCT06978660
Where you'd take part
This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Centre Hospitalier Universitaire de Toulouse
Toulouse, Franceno site contact published
Recruiting
Hospital Universitario Son Llàtzer
Palma de Mallorca, Balearic Islands, Spainno site contact published
Recruiting
Queen Elizabeth University Hospital, Univeisity of Glasgow
Glasgow, United Kingdomno site contact published
Recruiting
TUM Klinikum Deutsches Herzzentrum
München, Germanyno site contact published
Not yet recruiting
Hospital Universitario Donostia
San Sebastián, Guipúzcoa, Spainno site contact published
Completed
Hospital Universitario Juan Ramón Jiménez
Huelva, Huelva, Spainno site contact published
Completed
Northwestern University
Evanston, Illinoisno site contact published
Completed
Universitätsklinikum Bonn
Bonn, Germanyno site contact published
Completed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Pablo García Pavía, MD, PhD · PRINCIPAL_INVESTIGATOR · Hospital Universitario Puerta de Hierro
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Device performanceBaseline (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.