E85.4 I43.1
Conditions
Interventions
Group 1: A retrospective analysis of all patients diagnosed with cardiac ATTR amyloidosis between January 1, 2015, and December 31, 2025. This non-interventional, retrospective observational study doe
Sponsors
Idoven 1903 S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years Availability of at least one digitally stored 12-lead resting ECG (raw data, e.g. XML or DICOM) acquired as part of routine clinical care Patients with confirmed transthyretin cardiac amyloidosis (ATTR), or appropriate control subjects without cardiac amyloidosis Availability of relevant baseline clinical data (e.g. demographics and diagnostic status)
Exclusion criteria
Exclusion criteria: Missing or technically non-interpretable ECG raw data ECGs not acquired as part of routine clinical care Incomplete or non-verifiable diagnostic information (e.g. unclear ATTR status) Age < 18 years Datasets not eligible for lawful secondary use in accordance with GDPR and applicable data protection regulations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Diagnostic performance of the AI platform, including sensitivity, specificity, accuracy, positive and negative predictive values, and F1 score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Performance of the AI algorithm on ECGs that do not fully meet predefined quality criteria - Exploratory multimodal analyses integrating ECG data with clinical parameters and imaging findings | — |
Countries
France, Germany, Italy, Spain
Contacts
Public ContactCan Öztürk
Universitätsklinikum Bonn
Outcome results
None listed