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Tests an AI tool on heart ECGs to spot transthyretin cardiac amyloidosis

Tests an AI platform reading heart tracings to detect cardiac amyloidosis in adults.

Key facts

Who runs it
Idoven 1903 S.L.
Where
Bonn and München, GermanySee the 2 sitesAlso in 4 other countries, 6 sites
Trial code
Registry title
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
Status
Recruiting
People taking part
2,200 people, planned
Started
27 May 2025
Expected to end
Jan 2027
Type of study
Observational, 2 groups
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The study looks at past ECG records of adults, some with transthyretin cardiac amyloidosis and some without. It tests a computer tool that reads ECGs.

Age
18 years or older
Sex
All sexes
Biomarker or test result
A digital 12-lead ECG recording that is at least 10 seconds long

Main reasons for not taking part

  • ECG shows a paced rhythm

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • Subjects ≥ 18 years old
  • Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format

Who cannot take part

  • Patients with paced rhythm on the ECG

Where in Germany

Also in 4 other countries, 6 sites

  • Universitätsklinikum BonnBonn, GermanyContact: Manuel Marina-Breysse, MSc, MDNo longer taking part
  • TUM Klinikum Deutsches HerzzentrumMünchen, GermanyContact: Moritz von Scheidt, MD, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
Plain-language title
Tests an AI tool on heart ECGs to spot transthyretin cardiac amyloidosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 November 2026