Recruiting

Willem™

Sponsor:

Idoven 1903 S.L.

Code:

NCT06978660

Conditions

Transthyretin Cardiac Amyloidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06978660

Start date

May 27, 2025

Status verified date

Feb, 2026

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Device performance [ Time Frame: Baseline (closest clinical assessment to ATTR-CA diagnosis) ]

Central Contacts and Locations

Central contacts

Manuel Marina-Breysse, MSc, MD

+34618103160m@idoven.ai

José María Lillo, PhD

c@idoven.ai

Locations

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Principal Investigator:

Faraz Ahmad, MD, MS

More Information

Sponsor

Idoven 1903 S.L.

Last update posted

Mar 16, 2026

Last verified

Feb, 2026

Keywords

  • Transthyretin cardiac amyloidosis
  • ATTR
  • AI-based ECG Analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Idoven 1903 S.L. on 2026-03-16.