protocolSection identificationModule nctId: NCT06310707, orgStudyIdInfo id: EU RCT: ePatch vs 24h Holter, secondaryIdInfos id: 2022-A02338-35, type: OTHER, domain: ANSM, French competent authority, secondaryIdInfos id: EA4/071/23, type: OTHER, domain: German Ethics Committee_Charité Universitätsmedizin Berlin, briefTitle: Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-09, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Philips Clinical & Medical Affairs Global, class: INDUSTRY, descriptionModule briefSummary: This study is a Multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring., conditionsModule conditions: Arrythmia, conditions: Syncope, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-center, prospective, randomized, unblinded, two-arm study, to include approximately 128 subjects treated with the ePatch Extended Wear Holter (worn for 7 days) and approximately 128 subjects treated with a Standard Wear Holter (worn for 24 hours). Randomization will be balanced for gender., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: ePatch ® Extended Wear Holter (EWH), outcomesModule primaryOutcomes measure: Diagnostic yield (frequency) of clinically actionable arrythmia, secondaryOutcomes measure: Number of Atrial Fibrillation (AF) diagnoses > 30 seconds, secondaryOutcomes measure: Occurrence of symptomatic events, secondaryOutcomes measure: Number of Clinically actionable arrhythmia, secondaryOutcomes measure: Patient Quality of Life as measured by EQ-5D-5L, secondaryOutcomes measure: Patient Quality of Life as measured by Patient Experience Survey, secondaryOutcomes measure: Cost related to cardiac monitoring, secondaryOutcomes measure: Time Holter is worn/ removed, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel, status: RECRUITING, city: Bron, zip: 69677 Cedex, country: France, contacts name: Philippe Chevalier, MD PhD, role: CONTACT, phone: +33.472.357.027, email: philippe.chevalier@chu-lyon.fr, contacts name: Philippe Chevalier, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin, status: NOT_YET_RECRUITING, city: Berlin, zip: D-12203, country: Germany, contacts name: Tharusan Thevathasan, MD, role: CONTACT, phone: +49 1577 4407864, email: tharusan.thevathasan@dhzc-charite.de, contacts name: Tharusan Thevathasan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False