Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
Launched by IDOVEN 1903 S.L. · May 16, 2025
Trial Information
Current as of November 11, 2025
Recruiting
Keywords
ClinConnect Summary
The CONCERTO trial is studying a new technology that uses artificial intelligence (AI) to analyze electrocardiograms (ECGs)—which are tests that measure the heart's electrical activity. This study aims to see how well this AI-based platform, called Willem™, can identify a specific heart condition known as Transthyretin Cardiac Amyloidosis (ATTR-CA). By comparing the ECG results of patients diagnosed with ATTR-CA to those without the condition, researchers hope to validate whether this technology can help in diagnosing the disease earlier.
To participate in the trial, individuals must be at least 18 years old and have a digital record of a 12-lead ECG that lasts at least 10 seconds. However, patients with a paced heart rhythm (a condition where a device helps control the heart's rhythm) will not be eligible. At this point, the trial isn't actively recruiting participants yet, but it holds promise for improving how doctors can detect this serious heart condition in the future.
Gender
ALL
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.
About Idoven 1903 S.L.
Idoven 1903 S.L. is a biopharmaceutical company dedicated to advancing innovative solutions in the field of cardiovascular medicine. Focused on the development of cutting-edge therapies and diagnostic tools, Idoven leverages state-of-the-art technologies and a robust research framework to address unmet medical needs. With a commitment to improving patient outcomes, the company collaborates with leading experts and institutions to conduct rigorous clinical trials, ensuring the highest standards of safety and efficacy in its product pipeline.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Huelva, Spain
Toulouse, France
San Sebastián, Spain
Florence, Italy
Palma De Mallorca, Spain
Trieste, Italy
Patients applied
Trial Officials
Pablo García Pavía, MD, PhD
Principal Investigator
Hospital Universitario Puerta de Hierro
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported