Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 1:36 PM
Study NCT ID:
NCT04579159
Status:
COMPLETED
Last Update Posted:
2022-07-07
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study (Smart in OAC - AFNET 9)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 882}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-04', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study', 'timeFrame': 'Screening per participant: 4-8 weeks', 'description': 'Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study'}], 'secondaryOutcomes': [{'measure': 'Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording', 'timeFrame': 'Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months', 'description': 'Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording'}, {'measure': 'Time from completed enrolment to the first positive screening, taking death as compeeting risk into account', 'timeFrame': 'Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months', 'description': 'Time from completed enrolment to the first positive screening, taking death as compeeting risk into account'}, {'measure': 'Regional differences of AA prevalance (diagnostic yield)', 'timeFrame': 'Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months', 'description': 'Regional differences of AA prevalance (diagnostic yield)'}, {'measure': 'Differences by rout fo invitation and enrolment', 'timeFrame': 'Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months', 'description': 'Differences by rout fo invitation and enrolment'}, {'measure': 'Duration of atrial arrhythmia episodes', 'timeFrame': 'Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months', 'description': 'Duration of atrial arrhythmia episodes will be reported descriptively by mean, sd, range, median and IQR'}, {'measure': 'Follow-up EQ-5DL-5L viscual analogue scale of participants with positve PPG', 'timeFrame': 'Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months', 'description': 'Follow-up EQ-5DL-5L viscual analogue scale of participants with positve PPG'}, {'measure': 'Detection of AF: Number of participants with clinically confirmed arrhythmias during Holter ECG', 'timeFrame': 'Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months', 'description': 'Detection of AF: Number of participants with clinically confirmed arrhythmias during Holter ECG, documented clinically or by event-recorder'}, {'measure': 'Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable', 'timeFrame': 'Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months', 'description': 'Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable will be presented descriptively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Arrhythmia']}, 'referencesModule': {'references': [{'pmid': '36710894', 'type': 'DERIVED', 'citation': 'Fabritz L, Connolly DL, Czarnecki E, Dudek D, Guasch E, Haase D, Huebner T, Zlahoda-Huzior A, Jolly K, Kirchhof P, Obergassel J, Schotten U, Vettorazzi E, Winkelmann SJ, Zapf A, Schnabel RB; Smart in OAC-AFNET 9 investigators. Smartphone and wearable detected atrial arrhythmias in Older Adults: Results of a fully digital European Case finding study. Eur Heart J Digit Health. 2022 Nov 1;3(4):610-625. doi: 10.1093/ehjdh/ztac067. eCollection 2022 Dec.'}, {'pmid': '35387433', 'type': 'DERIVED', 'citation': 'Fabritz L, Connolly D, Czarnecki E, Dudek D, Zlahoda-Huzior A, Guasch E, Haase D, Huebner T, Jolly K, Kirchhof P, Schotten U, Zapf A, Schnabel RB. Remote Design of a Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study: Smart in OAC - AFNET 9. Front Cardiovasc Med. 2022 Mar 21;9:839202. doi: 10.3389/fcvm.2022.839202. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This feasibility study will develop and evaluate pathways to identify participants with wearable-detected absoulute Arrhythmia (AA) and to enable local study teams to contact them regarding participation in a controlled trial of oral anticoagulation in this population, which will be conducted after the feasibility study.', 'detailedDescription': 'In this study, the feasibility of evaluating the efficacy of a cloud based analytic service in combination with a PPG-wearable in detecting AA will be assessed and the number of cases found. The design aims to provide simple, low-threshold access to this screening technology targeting at-risk populations. This study will not cause any restrictions on the usual care of the study participants. Access to the screening will be provided close to home and free of charge. The app will also be used to validate and enhance the clinical information about the participants captured during the study. This information will be used to define and refine target groups with highest screening efficiency and, in the long-term, outcome benefits. The study will describe the prevalence of AA in an unselected population that can be reached by a low-threshold screening procedure. The study will also generate important information on the different possible screening environments in different countries (e.g. pharmacies, GP practices, etc). Structures of work-up and continuous patient management in screen-positive individuals will be described and may help to design screening pathways in the main trial. By verifying the wearable-diagnoses by ECG in all screen-positive and a random selection of screen-negative participants, the diagnostic accuracy of the wearable in combination of cloud based analytic service can be estimated. Cost effectiveness assessment will evaluate the cost of low-threshold remote screening per patient identified and help guide to target high risk groups with optimal screening yield in the future. The collected data will provide the sound basis for the design and conduct of a large outcome trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria:\n\n* 65 years or older\n* Willing and able to provide informed consent\n* Owning mobile phone compatible with the PPG-wearable\n\nExclusion criteria:\n\n* Known AF\n* Known current or planned oral anticoagulation treatment'}, 'identificationModule': {'nctId': 'NCT04579159', 'acronym': 'Smart in OAC', 'briefTitle': 'The Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study (Smart in OAC - AFNET 9)', 'organization': {'class': 'OTHER', 'fullName': 'Atrial Fibrillation Network'}, 'officialTitle': 'Multicentre, Intern., Inv.-Initiated, Single-arm Case-finding Study of a Cloud Based Analytic Service as Screening Tool to Detect and Quantify Episodes of Absolute Arrhythmia Using an Automated, Wearable PPG-based Monitoring System', 'orgStudyIdInfo': {'id': 'Smart in OAC - AFNET 9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'only control group', 'description': 'To investigate the specificity of the wearable and to gather more information on ECG abnormalities in the population studied, a randomly selected group of participants without wearable-detected AA within 8 weeks of screening (same number as screen-positives and verified by Telecare) will also be invited to obtain a 14day Tele ECG (patch).', 'interventionNames': ['Device: Preventicus heartbeat app in combination with wearables']}], 'interventions': [{'name': 'Preventicus heartbeat app in combination with wearables', 'type': 'DEVICE', 'description': 'CE certified devices', 'armGroupLabels': ['only control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitäres Herz- und Gefäßzentrum UKE Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '04416', 'city': 'Markkleeberg', 'country': 'Germany', 'facility': 'Kardiologische Praxis, Dr. med. Jens Taggeselle', 'geoPoint': {'lat': 51.2755, 'lon': 12.36906}}, {'zip': '31-514', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Krakowskie Centrum Diagnostyczno-Kliniczne (KCDK)', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': "Hospital Clínic Unitat d'Arrítmies, Institut Cardiovascular", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Larissa Fabritz, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atrial Fibrillation Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company', 'class': 'INDUSTRY'}, {'name': 'Preventicus GmbH', 'class': 'INDUSTRY'}, {'name': 'Corsano/ MMT', 'class': 'UNKNOWN'}, {'name': 'Getemed Medizin- und Informationstechnik', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}