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Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
NCT06978660 · View on ClinicalTrials.gov ↗
Study 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 Studied
Study Locations (10)
Other
- Centre Hospitalier Universitaire de Toulouse — Toulouse
- Universitätsklinikum Bonn — Bonn
- L'Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi — Bologna
- Careggi University Hospital — Florence
- United Hospitals of Trieste University Hospital — Trieste
- Queen Elizabeth University Hospital, Univeisity of Glasgow — Glasgow
Illinois
- Northwestern University — Evanston
Balearic Islands
- Hospital Universitario Son Llàtzer — Palma de Mallorca
Guipúzcoa
- Hospital Universitario Donostia — San Sebastián
Huelva
- Hospital Universitario Juan Ramón Jiménez — Huelva
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2025-05-27 |
| Est. Completion | 2026-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06978660
The ClinicalTrials.gov registry entry for NCT06978660 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Idoven 1903 S.L., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Transthyretin Cardiac Amyloidosis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06978660 reports 10 study locations spanning 5 distinct geographic areas — top geographies include Other, Illinois, Balearic Islands. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06978660 about?
NCT06978660 is a clinical study titled "Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis". 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™ abil...
What is the current status of trial NCT06978660?
This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2025-05-27. Estimated completion is 2026-05.
What conditions does trial NCT06978660 study?
This clinical trial studies the following conditions: Transthyretin Cardiac Amyloidosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT06978660?
This trial is sponsored by Idoven 1903 S.L., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06978660 being conducted?
This trial has 10 study locations across Illinois, Balearic Islands, Guipúzcoa, Huelva. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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