protocolSection identificationModule nctId: NCT06322836, orgStudyIdInfo id: Protocol ID ABR number 83536, briefTitle: A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home, acronym: Electra-1, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: RAV Brabant MWN, class: OTHER, collaborators name: Jeroen Bosch Ziekenhuis, descriptionModule briefSummary: The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients.The main question\[s\] it aims to answer are:Primary objective:In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation).Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention.Secondary objectives:Safety endpoint:Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation).A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care., conditionsModule conditions: Emergency Medical Services, conditions: Electric Countershock, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: a pilot, non-controlled, non-randomised, single centre study. The Electra-1 pilot study is a prospective intervention feasibility study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Duble current electro cardioversion, outcomesModule primaryOutcomes measure: completion of cardioversion to sinus rhythm, secondaryOutcomes measure: Incidence of treatment-emergent adverse events (Safety endpoint a), secondaryOutcomes measure: Incidence of treatment-emergent adverse events (Safety endpoint b), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RAV Brabant MWN, city: 's-Hertogenbosch, state: Noord Brabant, zip: 5212VM, country: Netherlands, geoPoint lat: 51.69917, lon: 5.30417, hasResults: False