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NCT06978660 · ClinicalTrials.gov registry record
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
A clinical trial of Transthyretin Cardiac Amyloidosis, sponsored by Idoven 1903 S.L..
- Recruiting
- Registry status
- 2,000
- Enrollment target
- 10
- Study locations
NCT06978660: Recruiting study of Transthyretin Cardiac Amyloidosis, sponsored by Idoven 1903 S.L..
NCT06978660 is a study of Transthyretin Cardiac Amyloidosis that is actively recruiting participants, run by Idoven 1903 S.L.. The registered enrollment target is 2,000 participants, above the 136-participant average among 4 other Transthyretin Cardiac Amyloidosis trials with a reported enrollment target (1371% higher). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06978660, a study of Transthyretin Cardiac Amyloidosis, is actively recruiting participants, sponsored by Idoven 1903 S.L..
- RECRUITING
- Registry status
- 2,000 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
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.
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 |
What NCT06978660 shows while recruiting
NCT06978660 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 136-participant average among 4 other Transthyretin Cardiac Amyloidosis trials with a reported enrollment target (1371% higher).
The record links to 1 condition, with Transthyretin Cardiac Amyloidosis appearing as the primary indexed condition, and to 0 interventions.
NCT06978660 lists 10 locations in 5 states (Other, Illinois, Balearic Islands).
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.
Who is sponsoring clinical trial NCT06978660?
This trial is sponsored by Idoven 1903 S.L., which has 2 total clinical trials registered on ClinicalTrials.gov.
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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