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Search / Trial NCT06978660

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

Transthyretin Cardiac Amyloidosis Attr Ai Based Ecg Analysis

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.

Locations

Huelva, Spain

Toulouse, France

San Sebastián, Spain

Florence, Italy

Palma De Mallorca, Spain

Trieste, Italy

Patients applied

0 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