Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis

Recruiting Observational Study
Transthyretin Cardiac Amyloidosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
2,200 (estimated)
Sponsor
Idoven 1903 S.L. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Subjects ≥ 18 years old * Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format Exclusion Criteria: * Patients with paced rhythm on the ECG.
Contacts

Manuel Marina-Breysse, MSc, MD

+34618103160

m@idoven.ai

CONTACT

José María Lillo, PhD

c@idoven.ai

CONTACT