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

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Idoven 1903 S.L.
Study ID
NCT06978660
Status
Recruiting
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Conditions

  • Transthyretin Cardiac Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 27, 2025
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: ATTR-CA patients
    Adult patients with confirmed diagnosis of ATTR-CA
  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityEvanstonIllinois60208
Faraz Ahmad, MD, MS
Faraz Ahmad, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Evanston, IL

By research site
Northwestern University· Evanston, IL

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