Status:
RECRUITING
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
Lead Sponsor:
Idoven 1903 S.L.
Collaborating Sponsors:
AstraZeneca
Conditions:
Transthyretin Cardiac Amyloidosis
Eligibility:
All Genders
18+ years
Brief 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 Wille...
Detailed Description
Transthyretin cardiac amyloidosis (ATTR-CA) is an infiltrative cardiomyopathy affecting cardiac health. Results from clinical trials have shown the importance of early diagnosis to improve outcomes an...
Eligibility Criteria
Inclusion
- Subjects ≥ 18 years old
- Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format
Exclusion
- Patients with paced rhythm on the ECG.
Key Trial Info
Start Date :
May 27 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06978660
Start Date
May 27 2025
End Date
April 1 2026
Last Update
December 31 2025
Active Locations (7)
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1
Northwestern University
Evanston, Illinois, United States, 60208
2
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
3
Careggi University Hospital
Florence, Italy
4
United Hospitals of Trieste University Hospital
Trieste, Italy