[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415106":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":62,"collaborators":26,"id":66,"slug":26,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sentinel® Cerebral Protection System Group","EXPERIMENTAL","Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation",[13,14],"Device: Sentinel® Cerebral Protection System","Diagnostic Test: Magnetic Resonance Imaging",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard of Care Group","ACTIVE_COMPARATOR","Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Sentinel® Cerebral Protection System","A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIAGNOSTIC_TEST","Magnetic Resonance Imaging","Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation",[9,16],[33],"MRI",[35],{"name":36,"affiliation":5,"role":37},"Malini Madhavan, MBBS","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Grace Purkey","CONTACT","(507) 255-0774","Purkey.Grace@mayo.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-92.4699,44.02163,{"lat":57,"lon":56},[60,61],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},{"name":36,"role":37,"phone":26,"phoneExt":26,"email":26},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Malini Madhavan","Principal Investigator","100415106",false,"NCT04685317","Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation","A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation","Inclusion Criteria:\n\n* Men \u002F women over the age of 18 years undergoing radiofrequency, pulsed field or cryo-balloon ablation for AF in accordance with the current AHA\u002FACC\u002FHRS guideline for management of patients with atrial fibrillation. This includes patients with symptomatic paroxysmal, persistent or long-standing persistent AF not responsive to or intolerant of a Class I or III anti-arrhythmic drug or patients with symptomatic paroxysmal or persistent AF prior to the initiation of a Class I or Class III antiarrhythmic drug). The decision to perform catheter ablation for AF will be made by the treating provider and the patient in accordance with the guidelines noted above. (January et al. J Am Coll Cardiol vol. 64, No. 21, 2014, page e1)\n* Able to provide informed consent.\n* Patients should have acceptable aortic arch anatomy and vessel diameters without significant stenosis as assessed using pre-procedure CT angiogram.\n\nExclusion Criteria:\n\n* Anatomy unsuitable for use of Sentinel device:\n\n  * Right extremity vasculature not suitable due to compromised arterial blood flow.\n  * Brachiocephalic, left carotid or aortic arch not suitable due to excessive tortuosity, significant ectasia, stenosis (\\>70%), dissection or aneurysm.\n* Cerebrovascular accident or transient ischemic attack within six months\n* Carotid disease requiring treatment within six weeks\n* Unable or unwilling to provide informed consent.\n* Pregnant women\n* Known history of dementia.\n* Known hypersensitivity to nickel-titanium.\n* Presence of MRI non-compatible implanted devices including cardiac implantable electronic devices.\n* The presence of left atrial thrombus. All patients routinely undergo transesophageal echocardiogram prior to ablation and \u002F or intra-cardiac echocardiogram at the beginning of the ablation procedure to rule out the presence of left atrial thrombus.\n* Patients with a reversible cause for AF such as hyperthyroidism.","ALL","18 Years",{"count":75,"type":76},48,"ESTIMATED","INTERVENTIONAL",[79],"NA","The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral protection device and those who do not receive the device.",[82,83],"Arrhythmia","Atrial Fibrillation","2025-06-09",{"date":86,"type":87},"2025-06-11","ACTUAL",{"date":89,"type":87},"2023-03-07",{"date":91,"type":76},"2026-12",{"name":64,"class":6},1]