Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-04 @ 1:02 AM
Study NCT ID:
NCT06028893
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (for Atrial Fibrillation Detection)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2023-08-31', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': 'Two months', 'description': 'Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.'}, {'measure': 'Specificity', 'timeFrame': 'Two months', 'description': 'Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.'}, {'measure': 'Overall accuracy (proportion of correct classifications)', 'timeFrame': 'Two months', 'description': 'Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.'}], 'secondaryOutcomes': [{'measure': 'Positive predictive value', 'timeFrame': 'Two months', 'description': 'Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®.'}, {'measure': 'Negative predictive value', 'timeFrame': 'Two months', 'description': 'Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®.'}, {'measure': 'Sensitivity by heart rate interval', 'timeFrame': 'Two months', 'description': 'Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.'}, {'measure': 'Specificity by heart rate interval', 'timeFrame': 'Two months', 'description': 'Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.'}, {'measure': 'Accuracy by heart rate interval', 'timeFrame': 'Two months', 'description': 'Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.'}, {'measure': 'Proportion of PPG measurements of insufficient quality for rhythm analysis', 'timeFrame': 'Two months', 'description': 'PPG measurements by FibriCheck®.'}, {'measure': 'Proportion of ECG measurements of insufficient quality for rhythm analysis', 'timeFrame': 'Two months', 'description': 'ECG measurements by Kardia Mobile®.'}, {'measure': 'Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval', 'timeFrame': 'Two months', 'description': 'PPG measurements by FibriCheck®.'}, {'measure': 'Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval', 'timeFrame': 'Two months', 'description': 'ECG measurements by Kardia Mobile®.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Photoplethysmography', 'Single-lead ECG', 'Electrocardiogram', 'Digital Health'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (PPG) technology on a smartphone have been developed. This study validates the performance of a digital health application (FibriCheck®) using PPG technology on a smartphone against a single-lead ECG device (Kardia Mobile®).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion.\n* Subject provides informed consent.\n* Subject understands and agrees to comply with planned study procedures.\n* Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home.\n\nExclusion Criteria:\n\n* Insufficient cognitive or comprehensive level of Dutch to participate to the trial.\n* No access to a smartphone or unable to perform FibriCheck measurements at home.\n* Pacemaker.'}, 'identificationModule': {'nctId': 'NCT06028893', 'acronym': 'RELATION PPG', 'briefTitle': 'REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (for Atrial Fibrillation Detection)', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuis Oost-Limburg'}, 'officialTitle': 'A Real-World Validation Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Atrial Fibrillation Detection', 'orgStudyIdInfo': {'id': 'Z-2021058-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'All subjects will perform heart rhythm measurements with both diagnostic tests.', 'interventionNames': ['Diagnostic Test: Heart rhythm measurements with FibriCheck®', 'Diagnostic Test: Heart rhythm measurements with Kardia Mobile®']}], 'interventions': [{'name': 'Heart rhythm measurements with FibriCheck®', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.', 'armGroupLabels': ['Study group']}, {'name': 'Heart rhythm measurements with Kardia Mobile®', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurements are performed immediately before and after every FibriCheck® measurement.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}