NCT06978660Recruiting
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2200 (estimated)
- First submitted
- 9 May 2025
- Start date
- 27 May 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Idoven 1903 S.L.
- Diseases
- Amyloidosis
- NCT number
- NCT06978660
What you commit to
- Study type: Observational
- Planned participants: 2200
- From 27 May 2025 to the primary completion date, 30 Sept 2026
- 8 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients with paced rhythm on the ECG.
Who the study is looking for
- Subjects ≥ 18 years old
- Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| TUM Klinikum Deutsches Herzzentrum Coordinator of this site? Confirm its status | München | Germany | Not yet recruiting |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Completed |
| Hospital Universitario Son Llatzer Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | San Sebastián | Spain | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Queen Elizabeth University Hospital, Univeisity of Glasgow Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Evanston | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.