RecruitingOBSERVATIONAL

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

This study, called CONCERTO, is looking at how well a new AI-powered tool, Willem™, can identify a heart condition called Transthyretin Cardiac Amyloidosis (ATTR-CA) using routine heart scans (ECGs). ATTR-CA affects the heart's health, and spotting it early can greatly improve how well treatments work. ECGs are common, non-invasive, and inexpensive, making them a good potential screening tool. Willem™ is already used to detect other heart patterns, and this study aims to see if it can also accurately distinguish between people with and without ATTR-CA based on their ECG results. This could lead to faster diagnoses for patients in the future.

At a glance

Status

Recruiting

Sponsor

Idoven 1903 S.L.

Enrolment target

2,000

Start

27 May 2025

Estimated completion

01 May 2026

Transthyretin Cardiac Amyloidosis

What is this study about?

Transthyretin Cardiac Amyloidosis (ATTR-CA) is a condition where abnormal proteins build up in the heart, making it harder for the heart to work properly. Catching this condition early is really important because it allows doctors to start treatments sooner, which has been shown to lead to better health outcomes for patients.

An electrocardiogram, or ECG, is a very common and simple test that records the electrical activity of your heart. It's safe, doesn't involve any needles or discomfort, and can provide a lot of information about how your heart is functioning. Because it's so widely used and easy to perform, researchers are exploring if it could be a valuable tool for spotting signs of ATTR-CA early on.

This study, called CONCERTO, is focusing on a new artificial intelligence (AI) platform named Willem™. Willem™ is designed to analyse ECG results to identify various heart patterns. The aim of this study is to test if Willem™ can accurately pick out the specific signs of ATTR-CA from routine ECGs. Essentially, they are checking if the AI can tell the difference between ECGs from people who definitely have ATTR-CA and those who don't. This research uses existing ECG data, meaning no new tests are performed on patients.

Key takeaways

The study uses existing ECG heart scans.
It's testing an AI tool (Willem™) to spot a heart condition called ATTR-CA.
Early diagnosis of ATTR-CA is important for better treatment.
ECGs are a common, safe, and inexpensive test.
The study aims to make diagnosis faster and simpler for future patients.

Who may be eligible?

To be included in this study, participants must be at least 18 years old. They also need to have had a specific type of heart tracing, an ECG, which recorded their heart's activity for at least 10 seconds and is available in a digital format.

People will not be included if their ECG shows they have a pacemaker, as this can affect the heart's electrical signals in a way that might interfere with the AI analysis.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 18 years old or older.
I have had a standard 12-lead ECG.
My ECG recorded for at least 10 seconds and is in digital format.
I do not have a pacemaker.

Answer every question to see your result.

What does participation involve?

This study is looking back at existing medical records, specifically pre-recorded ECGs, rather than involving new patient visits or procedures. This means that if you were part of this study, you wouldn't need to take any medication, attend appointments, or have any follow-up tests. Your participation would simply involve researchers using anonymous data from your past ECGs. There are no direct participant actions required.

Potential risks and benefits

Since this study only uses existing, anonymous ECG data and does not involve any direct patient contact, new medical procedures, or changes to your care, there are no direct physical risks to participants. The potential benefits are for future patients, as a successful outcome could lead to a faster and simpler way to diagnose ATTR-CA, allowing for earlier treatment. All patient data used in the study is kept confidential and anonymised. As no new treatments or interventions are given, there's no right to withdraw from a specific intervention, as none are applied.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Northwestern University
Verified postcode
Evanston, United States· Recruiting
Centre Hospitalier Universitaire de Toulouse
Verified postcode
Toulouse, France· Recruiting
Universitätsklinikum Bonn
Verified postcode
Bonn, Germany· Recruiting
L'Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Verified postcode
Bologna, Italy· Not yet recruiting
Careggi University Hospital
Verified postcode
Florence, Italy· Not yet recruiting
United Hospitals of Trieste University Hospital
Verified postcode
Trieste, Italy· Not yet recruiting
Hospital Universitario Son Llàtzer
Verified postcode
Palma de Mallorca, Spain· Recruiting
Hospital Universitario Donostia
Verified postcode
San Sebastián, Spain· Recruiting
Hospital Universitario Juan Ramón Jiménez
Verified postcode
Huelva, Spain· Recruiting
Queen Elizabeth University Hospital, Univeisity of Glasgow
Verified postcode
Glasgow, United Kingdom· Not yet recruiting

Common questions

What is Transthyretin Cardiac Amyloidosis (ATTR-CA)?

It's a heart condition where special proteins build up in the heart muscle, making it stiff and less able to pump blood effectively.

What is an ECG?

An ECG is a common, painless test that measures the electrical activity of your heart. It involves sticky pads placed on your skin.

What is Willem™?

Willem™ is a special computer programme that uses artificial intelligence to look at ECG results and help identify heart problems.

Will I have to do anything if I participate in this study?

No. This study uses existing, anonymous medical records, so you wouldn't need to attend any appointments or have any tests.

Why is this research important?

It could help doctors diagnose ATTR-CA earlier, which is really important for getting people the right treatment sooner and improving their health.

How to find out more

Manuel Marina-Breysse, MSc, MD

m@idoven.ai +34618103160 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.