[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506314":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":71,"collaborators":26,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":26,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":26,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":26,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Ziv HealthCare Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RR2 wearable home-care: active device","ACTIVE_COMPARATOR","Real stimulation with RR2 neuromodulation device",[13],"Device: Neuromodulation with RR2 device",{"label":15,"type":16,"description":17,"interventionNames":18},"RR2 wearable home-care: sham control device","SHAM_COMPARATOR","Mock sham stimulation with RR2 neuromodulation device",[19],"Device: Mock sham neuromodulation with sham RR2 device",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Neuromodulation with RR2 device","non-invasive neuromodulation with RR2 device",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Mock sham neuromodulation with sham RR2 device","Mock sham stimulation with RR2 device",[15],[32],{"name":33,"affiliation":34,"role":35},"Ehud Chorin, MD","Tel Aviv Souraski Medical Center, Department of Cardiology","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Adi Benari, MSc","CONTACT","+972-52-3863087","adi.b@my-cardiacare.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Amos Ziv","+972524419884","amos@my-cardiacare.com",[47,62],{"facility":48,"status":49,"city":50,"state":26,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Tel Aviv Sourasky Medical Center","RECRUITING","Tel Aviv","64239","Israel","IL",{"type":55,"coordinates":56},"Point",[57,58],34.78057,32.08088,{"lat":58,"lon":57},[61],{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":63,"status":64,"city":50,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"Clalit Health Services (HMO)","NOT_YET_RECRUITING",{"type":55,"coordinates":66},[57,58],{"lat":58,"lon":57},[69],{"name":70,"role":39,"phone":26,"phoneExt":26,"email":26},"Yelena Kyef",{"type":72,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100506314","beat-af---braking-ectopic-atrial-trends-in-atrial-fibrillation-100506314",false,"NCT05872776","BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation","A Multi Center Randomized, Double Blinded, Sham Controlled, Clinical Study Aimed to Determine the Efficacy of CardiaCare™ RR2 Home-care Neuromodulation System in Reducing Atrial Fibrillation Burden and Symptoms in Paroxysmal AF Patients","Inclusion Criteria:\n\n* Men and women ages 18-85 years with history of documented paroxysmal (\\\u003C7 days) atrial fibrillation\n* AF Burden (% time in AF) of more than 0.5% and less than 25% as evident by a continuous 14 days ECG recording at baseline (at minimum 168 hours)\n* Ability and willingness to sign an informed consent form\n* Ability and willingness to use CardiaCare home care device and ECG chest patch and has an available smart phone\n* Known symptomatic AF event over the recent 3 months\n* Willing not to change the antiarrhythmic treatment\n\nExclusion Criteria:\n\n* Hemodynamic instability (systolic blood pressure \\\u003C100mmHg or heart rate\\>170 bpm at Baseline) during recruitment visit\n* Known history or current diagnosis of atrial flutter\n* An active myocardial infarction evident from ECG\n* Recent stroke or myocardial infarction (\\\u003C6 months)\n* History of sick sinus syndrome 2nd or 3rd degree AV block, bifascicular block or prolonged (PR\\>300ms) 1st degree AV block\n* Unilateral or bilateral vagotomy\n* History of persistent AF with documented AF episodes of \\>7 days\n* Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases or valvular AF)\n* History of Impaired systolic function with EF\\\u003C40 % or NY Class III or IV heart failure classification\n* Dilatated left atria with a diameter \\> 50mm as evident by an echocardiogram\n* Currently enrolled in another study\n* Recurrent vaso-vagal syncopal episodes\n* Pregnancy or breast feeding\n* Pacemaker or CRTD or any implanted electrical stimulating device\n* History of epilepsy or seizures\n* Peripheral neuropathy or dermatological condition affecting the tested upper extremity area\n* Unsuitable for participating in the study according to attending physician","ALL","18 Years","85 Years",{"count":84,"type":85},50,"ESTIMATED","INTERVENTIONAL",[88],"NA","Paroxysmal AF subjects with a documented ECG event of AF will be recruited to the study To assess the efficacy of CardiaCare™ RR2 wearable home-care neuromodulation system in reducing AF burden and symptoms in Paroxysmal AF patients",[91],"Paroxysmal Atrial Fibrillation","2024-06-18",{"date":94,"type":95},"2024-06-20","ACTUAL",{"date":97,"type":95},"2023-02-16",{"date":99,"type":85},"2025-03",{"name":5,"class":6},2]