ClinicalTrials.gov record NCT06978660

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationFrance, Germany, Spain, United Kingdom, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a retrospective, observational, multicenter case-control study using existing 12-lead ECG data. It tests the Willem™ cloud-based AI ECG analysis platform to see if it can distinguish confirmed ATTR-CA patients from confirmed non-ATTR-CA subjects. The study also evaluates performance on ECGs that do not meet pre-specified quality requirements.

What it is studying. The study is testing whether the Willem™ AI-based ECG analysis platform can tell apart people with a confirmed diagnosis of transthyretin cardiac amyloidosis (ATTR-CA) from people who were suspected but confirmed not to have ATTR-CA, using stored 12-lead ECG recordings. It will measure standard diagnostic performance metrics (for example accuracy, sensitivity, specificity, positive and negative predictive values, and F1-score).

What the researchers hope to learn. To validate the diagnostic performance of the Willem™ AI ECG platform for identifying ATTR-CA from ECGs and to assess how well it performs when ECG data quality is sub-optimal. Results aim to provide evidence about the platform's accuracy, sensitivity, specificity, positive and negative predictive values, and F1-score.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This retrospective study uses existing digital 12‑lead ECG recordings (≥10 seconds) and the participant's diagnostic status from medical records. The ECG files will be analyzed by the Willem™ AI ECG platform to assess its ability to distinguish confirmed ATTR‑CA cases from non‑ATTR‑CA subjects, including analyses of sub‑optimal ECG quality. The registry does not specify any new visits, procedures, or tests required for participants.

How the study is structured. A retrospective observational case-control study. Investigators will analyze existing digital 12-lead ECG recordings from two groups—patients with confirmed ATTR-CA and controls confirmed not to have ATTR-CA—and run them through the Willem™ platform. There is no treatment or new testing; the study uses previously collected ECG data and clinical diagnoses for comparison.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France, Germany, Spain, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 27, 2025
Primary completion
Sep 30, 2026 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
2200 participants (estimated)
Last updated on registry
Jul 20, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Idoven 1903 S.L.
Collaborators
  • AstraZeneca

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (8)

  • Northwestern UniversityCompleted

    Evanston, Illinois, 60208 · United States

  • Centre Hospitalier Universitaire de ToulouseRecruiting

    Toulouse, 31300 · France

    • Olivier Lairez, MD, PhD
    • Olivier Lairez, MD, PhD
  • Universitätsklinikum BonnCompleted

    Bonn, 53127 · Germany

  • TUM Klinikum Deutsches HerzzentrumNot Yet Recruiting

    München, 80636 · Germany

    • Moritz von Scheidt, MD, PhD
    • Moritz von Scheidt, MD, PhD
  • Hospital Universitario Son LlàtzerRecruiting

    Palma de Mallorca, Balearic Islands, 07198 · Spain

    • Tomás Ripoll Vera, MD, PhD
    • Tomás Ripoll Vera, MD, PhD
    • María Eugenia Cisneros Barroso, MD, PhD
    • Ana María Far Riera, MD, PhD
  • Hospital Universitario DonostiaCompleted

    San Sebastián, Guipúzcoa, 20014 · Spain

  • Hospital Universitario Juan Ramón JiménezCompleted

    Huelva, Huelva, 21005 · Spain

  • Queen Elizabeth University Hospital, Univeisity of GlasgowRecruiting

    Glasgow, G51 4TF · United Kingdom

    • David Lowe, MD, MSc
    • David Lowe, MD, MSc

Terms used on this page · explanations by MedicalUpdates.ai

single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
electrocardiogram
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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