[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ziv HealthCare Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"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",[26],"Paroxysmal Atrial Fibrillation","RECRUITING","2024-06-18",{"date":30,"type":31},"2024-06-20","ACTUAL",{"date":33,"type":31},"2023-02-16",{"date":35,"type":20},"2025-03",{"name":37,"class":38},"Ziv HealthCare Ltd.","INDUSTRY",2,""]