Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06978660
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-16', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device performance', 'timeFrame': 'Baseline (closest clinical assessment to ATTR-CA diagnosis)', 'description': '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.\n\nThe diagnostic performance metrics will be accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score.'}], 'secondaryOutcomes': [{'measure': 'Device performance with sub-optimal ECG data quality', 'timeFrame': 'Baseline (closest clinical assessment to ATTR-CA diagnosis)', 'description': 'Assessment of Willem ability to distinguish between confirmed diagnosed ATTR-CA patients and subjects with no ATTR-CA diagnosis from ECG data which does not meet the minimum pre-specified quality requirements.\n\nThe diagnostic performance metrics will be accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transthyretin cardiac amyloidosis', 'ATTR', 'AI-based ECG Analysis'], 'conditions': ['Transthyretin Cardiac Amyloidosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Transthyretin cardiac amyloidosis (ATTR-CA) is an infiltrative cardiomyopathy affecting cardiac health. Results from clinical trials have shown the importance of early diagnosis to improve outcomes and maximize treatment efficacy.\n\nAn electrocardiogram (ECG) is the most commonly performed cardiac diagnostic procedure, providing a large amount of information that can reflect cardiac structure and physiology. In this regard, ECG could be an ideal screening tool for ATTR-CA given its wide use, non-invasive nature, low cost and high sensitivity to reflect ATTR-CA abnormalities.\n\nThe CE-marked Willem™ ECG Analysis platform has already shown its capability to process ECG data to detect cardiac patterns and arrythmias. This retrospective, observational, multicentric and single-arm study aims to expand the capabilities of the Willem™ ECG Analysis platform, in this case to detect ATTR-CA from ECG analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with a suspected or confirmed diagnosis of ATTR-CA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects ≥ 18 years old\n* Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format\n\nExclusion Criteria:\n\n* Patients with paced rhythm on the ECG.'}, 'identificationModule': {'nctId': 'NCT06978660', 'acronym': 'CONCERTO', 'briefTitle': 'Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idoven 1903 S.L.'}, 'officialTitle': 'Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)', 'orgStudyIdInfo': {'id': 'CON_1b'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ATTR-CA patients', 'description': 'Adult patients with confirmed diagnosis of ATTR-CA'}, {'label': 'Controls (non ATTR-CA subjects)', 'description': 'Adult subjects suspected of ATTR-CA, but finally confirmed not to have ATTR-CA'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Lairez, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Universitaire de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Florence', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Cappelli, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Careggi University Hospital', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Trieste', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Merlo, MD, PhD', 'role': 'CONTACT'}], 'facility': 'United Hospitals of Trieste University Hospital', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Huelva', 'state': 'Huelva', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Manovel, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital Juan Ramón Jiménez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Palma de Mallorca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Tomás Ripoll, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Son Llatzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'San Sebastián', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Xavier Arana, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}], 'centralContacts': [{'name': 'Manuel Marina-Breysse, MSc, MD', 'role': 'CONTACT', 'email': 'm@idoven.ai', 'phone': '+34618103160'}, {'name': 'José María Lillo, PhD', 'role': 'CONTACT', 'email': 'c@idoven.ai'}], 'overallOfficials': [{'name': 'Pablo García Pavía, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Puerta de Hierro'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Idoven 1903 S.L.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}