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

NCT06978660 | Recruiting

• 1 other identifier: CON_1b
• Study Type: observational
• Target: 2,000
• Locations: 6 countries
• Sites: 10

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.

Conditions

Transthyretin Cardiac Amyloidosis

Keywords

Transthyretin cardiac amyloidosis; ATTR; AI-based ECG Analysis

Outcome Measures

Primary Outcomes (1)

• Device performance

  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.

  Baseline (closest clinical assessment to ATTR-CA diagnosis)

Secondary Outcomes (1)

• Device performance with sub-optimal ECG data quality

  Baseline (closest clinical assessment to ATTR-CA diagnosis)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a suspected or confirmed diagnosis of ATTR-CA

You may qualify if:

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

You may not qualify if:

• Patients with paced rhythm on the ECG.

Sponsors & Collaborators

• Idoven 1903 S.L.: lead
• AstraZeneca: collaborator

Study Sites (10)

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31300, France

RECRUITING

Universitätsklinikum Bonn

Bonn, 53127, Germany

RECRUITING

L'Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

NOT YET RECRUITING

Careggi University Hospital

Florence, 50134, Italy

NOT YET RECRUITING

United Hospitals of Trieste University Hospital

Trieste, 34128, Italy

NOT YET RECRUITING

Hospital Universitario Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

RECRUITING

Hospital Universitario Donostia

San Sebastián, Guipúzcoa, 20014, Spain

RECRUITING

Hospital Universitario Juan Ramón Jiménez

Huelva, Huelva, 21005, Spain

RECRUITING

Queen Elizabeth University Hospital, Univeisity of Glasgow

Glasgow, G51 4TF, United Kingdom

NOT YET RECRUITING

Study Officials

• Pablo García Pavía, MD, PhD

  Hospital Universitario Puerta de Hierro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Marina-Breysse, MSc, MD

CONTACT

+34618103160; m@idoven.ai

José María Lillo, PhD

CONTACT

c@idoven.ai

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: May 27, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); IT (3); US (1); FR (1); DE (1); GB (1)