Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subjects ≥ 18 years old
• Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format
Locations
United States
Illinois
Northwestern University
COMPLETED
Evanston
Other Locations
France
Centre Hospitalier Universitaire de Toulouse
RECRUITING
Toulouse
Germany
Universitätsklinikum Bonn
COMPLETED
Bonn
TUM Klinikum Deutsches Herzzentrum
NOT_YET_RECRUITING
München
Spain
Hospital Universitario Juan Ramón Jiménez
COMPLETED
Huelva
Hospital Universitario Son Llàtzer
RECRUITING
Palma De Mallorca
Hospital Universitario Donostia
COMPLETED
San Sebastián
United Kingdom
Queen Elizabeth University Hospital, Univeisity of Glasgow
RECRUITING
Glasgow
Contact Information
Primary
Manuel Marina-Breysse, MSc, MD
m@idoven.ai
+34618103160
Backup
José María Lillo, PhD
c@idoven.ai
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2200
Treatments
ATTR-CA patients
Adult patients with confirmed diagnosis of ATTR-CA
Controls (non ATTR-CA subjects)
Adult subjects suspected of ATTR-CA, but finally confirmed not to have ATTR-CA
Related Therapeutic Areas
Sponsors
Collaborators: AstraZeneca
Leads: Idoven 1903 S.L.