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NCT Number: NCT06978660

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

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.

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Key information

Conditions

Transthyretin Cardiac Amyloidosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Toulouse, Toulouse, France

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About this study

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 and maximize treatment efficacy.

An electrocardiogram (ECG) is the most commonly performed cardiac diagnostic procedure, providing a large amount of information that can reflect cardiac structure and physiology. In this regard, ECG could be an ideal screening tool for ATTR-CA given its wide use, non-invasive nature, low cost and high sensitivity to reflect ATTR-CA abnormalities.

The CE-marked Willem™ ECG Analysis platform has already shown its capability to process ECG data to detect cardiac patterns and arrythmias. This retrospective, observational, multicentric and single-arm study aims to expand the capabilities of the Willem™ ECG Analysis platform, in this case to detect ATTR-CA from ECG analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Device performance

    Time frame: Baseline (closest clinical assessment to ATTR-CA diagnosis)

    Assessment of Willem ability to distinguish between confirmed diagnosed ATTR-CA patients and subjects with no ATTR-CA diagnosis from ECG data of sufficient quality.

    The diagnostic performance metrics will be accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score.

Secondary outcomes

  1. Device performance with sub-optimal ECG data quality

    Time frame: Baseline (closest clinical assessment to ATTR-CA diagnosis)

    Assessment of Willem ability to distinguish between confirmed diagnosed ATTR-CA patients and subjects with no ATTR-CA diagnosis from ECG data which does not meet the minimum pre-specified quality requirements.

    The diagnostic performance metrics will be accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score.

Study contacts

Contact information is provided by the study sponsor or research team.

José María Lillo, PhD

CONTACT

[email protected]

Manuel Marina-Breysse, MSc, MD

CONTACT

[email protected]

+34618103160

Sponsors and collaborators

Lead sponsor

Idoven 1903 S.L.

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Acronym: CONCERTO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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