Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
Status: Recruiting
Location: See all (6) 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
Other Locations
France
Centre Hospitalier Universitaire de Toulouse
NOT_YET_RECRUITING
Toulouse
Italy
Careggi University Hospital
NOT_YET_RECRUITING
Florence
United Hospitals of Trieste University Hospital
NOT_YET_RECRUITING
Trieste
Spain
Hospital Juan Ramón Jiménez
RECRUITING
Huelva
Hospital Universitario Son Llatzer
RECRUITING
Palma De Mallorca
Hospital Universitario Donostia
NOT_YET_RECRUITING
San Sebastián
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: 2025-10
Participants
Target number of participants: 500
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.