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

Sponsor: Idoven 1903 S.L.

NCT ID: NCT06978660

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 19 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study is checking whether an artificial intelligence (AI) computer programme can read ECG (electrocardiogram) heart traces to help find a heart condition called transthyretin cardiac amyloidosis early. It is running at more than one site, and it is paid for by a company called Idoven 1903 S.L.

Who can take part

  • Aged 18 or over
  • Have a 12-lead ECG (electrocardiogram) heart trace lasting at least 10 seconds, saved in digital format

Who may not be able to

  • Have a paced rhythm on the ECG (a heart rhythm set by a pacemaker)

What taking part involves

  • • Your ECG heart traces are read by an artificial intelligence (AI) platform to test whether it can help spot the condition early
  • • Anything else involved, such as medicines or other tests: Not stated — ask the trial team

Time commitment: Number of visits and study length: Not stated — ask the trial team; the record shows people taking part have digital ECG heart traces lasting at least 10 seconds.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
2,200
Started
2025-05-27
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for transthyretin cardiac amyloidosis
  • • Clinical study - 2,200 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with transthyretin cardiac amyloidosis

Where?

  • • Glasgow - Queen Elizabeth University Hospital, Univeisity of Glasgow

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Transthyretin Cardiac Amyloidosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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.
See the full 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.

Where Is This Study? (1 UK site)

Queen Elizabeth University Hospital, Univeisity of Glasgow

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)
David Lowe, MD, MScPrincipal Investigator

How to Get in Touch

Manuel Marina-Breysse, MSc, MD

Sponsor contact

CONTACT

+34618103160 m@idoven.ai

José María Lillo, PhD

Sponsor contact

CONTACT

c@idoven.ai
Data sourced from ClinicalTrials.gov · Last verified: 2026-07