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

March 13, 2026 updated by: Idoven 1903 S.L.

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Manuel Marina-Breysse, MSc, MD
  • Phone Number: +34618103160
  • Email: m@idoven.ai

Study Locations

  • France
      • Toulouse, France, 31300
        • Recruiting
        • Centre Hospitalier Universitaire de Toulouse
        • Contact:
          • Olivier Lairez, MD, PhD
        • Principal Investigator:
          • Olivier Lairez, MD, PhD
  • Germany
      • Bonn, Germany, 53127
        • Recruiting
        • Universitätsklinikum Bonn
        • Contact:
          • Can Öztürk, MD, PhD
        • Principal Investigator:
          • Can Öztürk, MD, PhD
  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • L'Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
        • Contact:
          • Elena Biagini, MD, PhD
        • Principal Investigator:
          • Elena Biagini, MD, PhD
        • Sub-Investigator:
          • Simone Longhi, MD, PhD
        • Sub-Investigator:
          • Irene Ruotolo, MD, PhD
      • Florence, Italy, 50134
        • Not yet recruiting
        • Careggi University Hospital
        • Contact:
          • Francesco Cappelli, MD, PhD
        • Principal Investigator:
          • Francesco Cappelli, MD, PhD
      • Trieste, Italy, 34128
        • Not yet recruiting
        • United Hospitals of Trieste University Hospital
        • Contact:
          • Marco Merlo, MD, PhD
        • Principal Investigator:
          • Marco Merlo, MD, PhD
  • Spain
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07198
        • Recruiting
        • Hospital Universitario Son LLatzer
        • Contact:
          • Tomás Ripoll Vera, MD, PhD
        • Principal Investigator:
          • Tomás Ripoll Vera, MD, PhD
        • Principal Investigator:
          • María Eugenia Cisneros Barroso, MD, PhD
        • Sub-Investigator:
          • Ana María Far Riera, MD, PhD
    • Guipúzcoa
      • San Sebastián, Guipúzcoa, Spain, 20014
        • Recruiting
        • Hospital Universitario Donostia
        • Contact:
          • Xabier Arana Achaga, MD, PhD
        • Principal Investigator:
          • Xabier Arana Achaga, MD, PhD
        • Sub-Investigator:
          • Cristina Goena Vives, MD, PhD
    • Huelva
      • Huelva, Huelva, Spain, 21005
        • Recruiting
        • Hospital Universitario Juan Ramon Jimenez
        • Contact:
          • Ana José Manovel Sánchez, MD, PhD
        • Principal Investigator:
          • Ana José Manovel Sánchez, MD, PhD
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Not yet recruiting
        • Queen Elizabeth University Hospital, Univeisity of Glasgow
        • Contact:
          • David Lowe, MD, MSc
        • Principal Investigator:
          • David Lowe, MD, MSc
  • United States
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Recruiting
        • Northwestern University
        • Contact:
          • Faraz Ahmad, MD, MS
        • Principal Investigator:
          • Faraz Ahmad, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with a suspected or confirmed diagnosis of ATTR-CA

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ATTR-CA patients
Adult patients with confirmed diagnosis of ATTR-CA
Controls (non ATTR-CA subjects)
Adult subjects suspected of ATTR-CA, but finally confirmed not to have ATTR-CA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (closest clinical assessment to ATTR-CA diagnosis)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (closest clinical assessment to ATTR-CA diagnosis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idoven 1903 S.L.

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Pablo García Pavía, MD, PhD, Hospital Universitario Puerta de Hierro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 9, 2025

First Submitted That Met QC Criteria

May 16, 2025

First Posted (Actual)

May 18, 2025

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CON_1b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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