Clinical trial NCT06978660: Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
Official title: Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transthyretin Cardiac Amyloidosis
Keywords: Transthyretin cardiac amyloidosis
ATTR
AI-based ECG Analysis
Lead sponsor: Idoven 1903 S.L.
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2025-05-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a suspected or confirmed diagnosis of ATTR-CA

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Device performance
timeFrame: Baseline (closest clinical assessment to ATTR-CA diagnosis)
Secondary outcomes:
measure: Device performance with sub-optimal ECG data quality
timeFrame: Baseline (closest clinical assessment to ATTR-CA diagnosis)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Florence
country: Italy
facility: Careggi University Hospital
city: Trieste
country: Italy
facility: United Hospitals of Trieste University Hospital
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Llatzer
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
Study officials:
affiliation: Hospital Universitario Puerta de Hierro
name: Pablo García Pavía, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: