Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT04281927
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2020-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Wearable With Photoplethysmography and 6-lead Electrocardiography 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015716', 'term': 'Electrocardiography, Ambulatory'}], 'ancestors': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 435}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-05', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of a wearable system for atrial fibrillation detection', 'timeFrame': 'PPG will be assessed in 2 minutes. ECG will be assessed in up to 10 months.', 'description': 'The wearable system comprises of two integrated components: a photoplethysmography (PPG) and a 6-lead ECG of the device. It works as described below.\n\nFirst, an automatic PPG algorithm will indicate whether atrial fibrillation is suspected. The rhythm assessment of PPG algorithm is based on pulse regularity.\n\nNext, a 6-lead ECG is acquired by the wearable. The rhythm assessment of ECG is based on P waves and regularity of QRS complexes. A diagnosis is made by independent cardiologists.\n\nThe conclusion of a whole system comprising of both described methods will be compared with a gold standard multi-lead Holter ECG. This standard ECG is also evaluated by independent cardiologists.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy of PPG algorithm of the wearable for atrial fibrillation detection', 'timeFrame': '2 minutes.', 'description': 'An automatic PPG algorithm will indicate whether atrial fibrillation is suspected. The rhythm assessment of PPG algorithm is based on pulse regularity. As a separate diagnostic tool it will be compared with a gold standard multi-lead Holter ECG which is assessed by independent cardiologists.'}, {'measure': 'Diagnostic accuracy of a 6-lead ECG of the wearable for atrial fibrillation detection', 'timeFrame': 'Up to 10 months.', 'description': 'Independent cardiologists will assess the heart rhythm in a 6-lead ECG acquired by the wearable. As a separate diagnostic tool it will be compared with a gold standard multi-lead Holter ECG which is also assessed by independent cardiologists. The rhythm evaluation of ECG is based on P waves and regularity of QRS complexes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wearable', 'electrocardiography', 'photoplethysmography'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants of defined groups will be enrolled in Vilnius University Hospital Santaros Clinics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with current ECG-based diagnosis of atrial fibrillation, sinus rhythm or sinus rhythm with frequent (at least once in 2 minutes) premature atrial or ventricular contractions.\n* Age is between 18 - 99.\n\nExclusion Criteria:\n\n* Participants who refuse to sign an informed consent.\n* Participants with atrial fibrillation who are currently in a paced rhythm.'}, 'identificationModule': {'nctId': 'NCT04281927', 'acronym': 'DoubleCheckAF', 'briefTitle': 'A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection', 'organization': {'class': 'OTHER', 'fullName': 'Vilnius University'}, 'officialTitle': 'A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection', 'orgStudyIdInfo': {'id': 'S-MIP-17-81'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial fibrillation', 'description': 'Patients with presumed atrial fibrillation will undergo monitoring with the device and Holter ECG.', 'interventionNames': ['Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)']}, {'label': 'Sinus rhythm', 'description': 'Patients with presumed sinus rhythm will undergo monitoring with the device and Holter ECG.', 'interventionNames': ['Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)']}, {'label': 'Sinus rhythm and frequent extrasystoles', 'description': 'Patients with presumed sinus rhythm and frequent extrasystoles will undergo monitoring with the device and Holter ECG.', 'interventionNames': ['Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)']}], 'interventions': [{'name': 'Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)', 'type': 'DEVICE', 'description': 'Participants will use the wearable (the tested device) to record at least 2 minutes of photoplethysmography and 6-lead ECG. In addition, each subject will be monitored with synchronous ECG Holter monitoring (with eMotion Faros 90).', 'armGroupLabels': ['Atrial fibrillation', 'Sinus rhythm', 'Sinus rhythm and frequent extrasystoles']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'Audrius Aidietis, Prof. PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vilnius University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vilnius University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaunas University of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}