[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613105":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":34,"responsibleParty":210,"collaborators":10,"id":212,"slug":213,"hasResults":214,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":10,"eligibilityCriteria":217,"healthyVolunteers":214,"sex":218,"minAge":219,"maxAge":10,"enrollmentInfo":220,"targetDuration":223,"studyType":224,"phases":10,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},{"fullName":5,"class":6},"Boston Scientific Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"WATCHMAN FLX Pro",null,"This arm is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device.\n\nApproximately 300 patients undergo the LAAC procedure in conjunction with the use of the VersaCross Connect™ LAAC Access Solution.",[13],"Device: Left atrial appendage closure",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Left atrial appendage closure","The WATCHMAN FLX Pro LAAC Technology is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in adult patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.\n\nThe VersaCross Connect™ LAAC Access Solution is indicated for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation \u002F puncture.",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Marek Grygier, Prof. MD, PHD","Uniwersytecki Szpital Kliniczny w Poznaniu","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Arian Sultan, Prof. MD","Asklepios Klinik Saint Georg",[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Thomas Näschen, PhD","CONTACT","+491707828594","Thomas.Naeschen@bsci.com",[35,51,63,77,88,97,106,120,133,147,160,172,184,198],{"facility":36,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Aarhus University Hospital","RECRUITING","Aarhus","8200","Denmark","DK",{"type":43,"coordinates":44},"Point",[45,46],10.21076,56.15674,{"lat":46,"lon":45},[49],{"name":50,"role":24,"phone":10,"phoneExt":10,"email":10},"Jens Erik Nielsen-Kudsk, Prof.",{"facility":52,"status":37,"city":53,"state":10,"zip":54,"country":40,"countryCode":41,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Rigshospitalet 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Monzino","Milan","20138","Italy","IT",{"type":43,"coordinates":113},[114,115],12.59836,42.78235,{"lat":115,"lon":114},[118],{"name":119,"role":24,"phone":10,"phoneExt":10,"email":10},"Claudio Tondo, Prof.",{"facility":23,"status":37,"city":121,"state":10,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Poznan","61-848","Poland","PL",{"type":43,"coordinates":126},[127,128],16.92993,52.40692,{"lat":128,"lon":127},[131],{"name":132,"role":24,"phone":10,"phoneExt":10,"email":10},"Marek Grygier, Prof.",{"facility":134,"status":37,"city":135,"state":10,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Hospital de Leon","León","24071","Spain","ES",{"type":43,"coordinates":140},[141,142],-5.57032,42.60003,{"lat":142,"lon":141},[145],{"name":146,"role":24,"phone":10,"phoneExt":10,"email":10},"Armando Perez de Prado, Prof.",{"facility":148,"status":37,"city":149,"state":10,"zip":150,"country":137,"countryCode":138,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Clinica Universidad de Navarra","Pamplona","31008",{"type":43,"coordinates":152},[153,154],-1.64323,42.81687,{"lat":154,"lon":153},[157,159],{"name":158,"role":31,"phone":10,"phoneExt":10,"email":10},"Jose Ignacio Garcia Bolao, Prof.",{"name":158,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":161,"status":37,"city":162,"state":10,"zip":163,"country":137,"countryCode":138,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Complejo Hospitalario Universitario de Pontevedra","Pontevedra","36001",{"type":43,"coordinates":165},[166,167],-8.64435,42.431,{"lat":167,"lon":166},[170],{"name":171,"role":24,"phone":10,"phoneExt":10,"email":10},"Diego Lopez Otero, MD",{"facility":173,"status":37,"city":174,"state":10,"zip":175,"country":137,"countryCode":138,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Hospital Clinico Salamanca","Salamanca","37007",{"type":43,"coordinates":177},[178,179],-5.66388,40.96882,{"lat":179,"lon":178},[182],{"name":183,"role":24,"phone":10,"phoneExt":10,"email":10},"Ignacio Cruz Gonzalez, Prof.",{"facility":185,"status":37,"city":186,"state":10,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"University Hospital Basel","Basel","4031","Switzerland","CH",{"type":43,"coordinates":191},[192,193],7.57327,47.55839,{"lat":193,"lon":192},[196],{"name":197,"role":24,"phone":10,"phoneExt":10,"email":10},"Christian Sticherling, Prof.",{"facility":199,"status":37,"city":200,"state":10,"zip":201,"country":188,"countryCode":189,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"INSELSPITAL - Universitätsspital Bern","Bern","CH-3010",{"type":43,"coordinates":203},[204,205],7.44744,46.94809,{"lat":205,"lon":204},[208],{"name":209,"role":24,"phone":10,"phoneExt":10,"email":10},"Lorenz Räber, Prof.",{"type":211,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100613105","watchman-flx-pro-european-registry-100613105",false,"NCT07262255","WATCHMAN FLX Pro European Registry","Inclusion Criteria:\n\n1. Subject is attempted to be treated with the WATCHMAN FLX™ Pro LAAC device.\n2. Subject has non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve) and is clinically indicated for a WATCHMAN FLX™ Pro LAAC device, per the Instructions for Use (IFU).\n3. Subject or legal representative who are willing and capable of providing informed consent.\n4. Subject is able and willing to return for required follow-up visits and examinations.\n5. Subject whose age is 18 years or above, or who is of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Subject has a documented life expectancy of less than 12 months.\n2. Subject who is currently enrolled in another investigational study or registry except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.\n3. Intracardiac thrombus is present.\n4. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.\n5. The LAA anatomy will not accommodate a Closure Device.\n6. Subject has a known hypersensitivity or contraindications according to IFU.\n7. Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.","ALL","18 Years",{"count":221,"type":222},1000,"ESTIMATED","12 Months","OBSERVATIONAL","The WATCHMAN FLX Pro European registry is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device. In a subregistry with approximately 300 patients, it is intended to use the VersaCross Connect™ LAAC Access Solution.",[227,228],"Non-valvular Atrial Fibrillation (AF)","Left Atrial Appendage Closure",[230],"LAAC","2026-06-23",{"date":233,"type":234},"2026-06-24","ACTUAL",{"date":236,"type":234},"2025-12-17",{"date":238,"type":222},"2028-09",{"name":5,"class":6},14]