NCT06978660 Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
| NCT ID | NCT06978660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Idoven 1903 S.L. |
| Condition | Transthyretin Cardiac Amyloidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2025-05-27 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Pablo García Pavía, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital Universitario Puerta de Hierro
Frequently Asked Questions
Who can join the NCT06978660 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Transthyretin Cardiac Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06978660 currently recruiting?
Yes, NCT06978660 is actively recruiting participants. Contact the research team at m@idoven.ai for enrollment information.
Where is the NCT06978660 trial being conducted?
This trial is being conducted at Evanston, United States, Toulouse, France, Bonn, Germany, Bologna, Italy and 6 additional locations.
Who is sponsoring the NCT06978660 clinical trial?
NCT06978660 is sponsored by Idoven 1903 S.L.. The principal investigator is Pablo García Pavía, MD, PhD at Hospital Universitario Puerta de Hierro. The trial plans to enroll 2,000 participants.