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

Not yet recruiting

• Conditions: Transthyretin Cardiac Amyloidosis

• Registration Number: NCT06978660
• Lead Sponsor: Idoven 1903 S.L.

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.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device performance	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.

Secondary Outcome Measures

Name	Time	Method
Device performance with sub-optimal ECG data quality	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.

Trial Locations

Locations (5)

Hospital Universitario Son Llatzer; 🇪🇸 Palma de Mallorca, Spain

United Hospitals of Trieste University Hospital; 🇮🇹 Trieste, Italy

Centre Hospitalier Universitaire de Toulouse; 🇫🇷 Toulouse, France

Careggi University Hospital; 🇮🇹 Florence, Italy

Hospital Universitario Donostia; 🇪🇸 San Sebastián, Spain