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

NCT ID: NCT06978660

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-27

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Transthyretin Cardiac Amyloidosis

Keywords

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Transthyretin cardiac amyloidosis ATTR AI-based ECG Analysis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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ATTR-CA patients

Adult patients with confirmed diagnosis of ATTR-CA

No interventions assigned to this group

Controls (non ATTR-CA subjects)

Adult subjects suspected of ATTR-CA, but finally confirmed not to have ATTR-CA

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Idoven 1903 S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pablo García Pavía, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Puerta de Hierro

Locations

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Northwestern University

Evanston, Illinois, United States

Site Status RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, , France

Site Status NOT_YET_RECRUITING

Careggi University Hospital

Florence, , Italy

Site Status NOT_YET_RECRUITING

United Hospitals of Trieste University Hospital

Trieste, , Italy

Site Status NOT_YET_RECRUITING

Hospital Juan Ramón Jiménez

Huelva, Huelva, Spain

Site Status RECRUITING

Hospital Universitario Son Llatzer

Palma de Mallorca, , Spain

Site Status RECRUITING

Hospital Universitario Donostia

San Sebastián, , Spain

Site Status RECRUITING

Countries

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United States France Italy Spain

Central Contacts

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Manuel Marina-Breysse, MSc, MD

Role: CONTACT

Phone: +34618103160

Email: [email protected]

José María Lillo, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Faraz Ahmad, MD, MS

Role: primary

Olivier Lairez, MD, PhD

Role: primary

Francesco Cappelli, MD, PhD

Role: primary

Marco Merlo, MD, PhD

Role: primary

Ana Manovel, MD, PhD

Role: primary

Tomás Ripoll, MD, PhD

Role: primary

Xavier Arana, MD, PhD

Role: primary

Other Identifiers

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CON_1b

Identifier Type: -

Identifier Source: org_study_id