[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568842":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":291,"collaborators":10,"id":293,"slug":10,"hasResults":294,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":294,"sex":299,"minAge":300,"maxAge":10,"enrollmentInfo":301,"targetDuration":10,"studyType":304,"phases":10,"briefSummary":305,"conditions":306,"keywords":10,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":320},{"fullName":5,"class":6},"Boston Scientific Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Subjects",null,"A subject is considered enrolled once an approved informed consent form has been signed and dated. Enrolled Subjects will undergo AF ablation procedure with the FARAPULSE PFA System, followed by WATCHMAN implant during the same procedure.",[13],"Device: FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems","The FARAPULSE™ PFA System consists of the FARAWAVE™ Pulsed Field Ablation Catheter, the FARASTAR™ Pulsed Field Ablation Generator, and the FARADRIVE™ Steerable Sheath.\n\nThe WATCHMAN LAA Closure Technology consists of the WATCHMAN Access System (which consists of the Access Sheath and Dilator and the WATCHMAN Delivery System (which consists of the delivery catheter and the pre-loaded closure device). The WATCHMAN Access System and WATCHMAN Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Jamie Kwek","CONTACT","+6564188833","Jamie.Kwek@bsci.com",[27,39,47,52,61,66,74,79,87,95,103,111,119,127,135,143,151,156,161,169,174,183,187,195,199,202,209,217,220,228,236,248,256,264,273,278,286],{"facility":28,"status":29,"city":30,"state":31,"zip":10,"country":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":10},"The First Affiliated Hospital of Soochow University","RECRUITING","Suzhou","Jiangsu","China",{"type":34,"coordinates":35},"Point",[36,37],120.59538,31.30408,{"lat":37,"lon":36},{"facility":40,"status":29,"city":41,"state":10,"zip":10,"country":32,"cosmosGeoPoint":42,"geoPoint":46,"contacts":10},"Beijing Anzhen Hospital of the Capital University of Medical Sciences","Beijing",{"type":34,"coordinates":43},[44,45],116.39723,39.9075,{"lat":45,"lon":44},{"facility":48,"status":29,"city":41,"state":10,"zip":10,"country":32,"cosmosGeoPoint":49,"geoPoint":51,"contacts":10},"Xuanwu Hospital Capital Medical University",{"type":34,"coordinates":50},[44,45],{"lat":45,"lon":44},{"facility":53,"status":54,"city":55,"state":10,"zip":10,"country":32,"cosmosGeoPoint":56,"geoPoint":60,"contacts":10},"Huaxi Hospital of Sichuan University","ACTIVE_NOT_RECRUITING","Chengdu",{"type":34,"coordinates":57},[58,59],104.06667,30.66667,{"lat":59,"lon":58},{"facility":62,"status":29,"city":55,"state":10,"zip":10,"country":32,"cosmosGeoPoint":63,"geoPoint":65,"contacts":10},"The First Affiliated Hospital of Chengdu Medical College",{"type":34,"coordinates":64},[58,59],{"lat":59,"lon":58},{"facility":67,"status":29,"city":68,"state":10,"zip":10,"country":32,"cosmosGeoPoint":69,"geoPoint":73,"contacts":10},"Guangdong Nanfang Hospital","Guangzhou",{"type":34,"coordinates":70},[71,72],113.25,23.11667,{"lat":72,"lon":71},{"facility":75,"status":29,"city":68,"state":10,"zip":10,"country":32,"cosmosGeoPoint":76,"geoPoint":78,"contacts":10},"The Third Affiliated Hospital of Guangzhou Medical University",{"type":34,"coordinates":77},[71,72],{"lat":72,"lon":71},{"facility":80,"status":29,"city":81,"state":10,"zip":10,"country":32,"cosmosGeoPoint":82,"geoPoint":86,"contacts":10},"The Affiliated Hospital of Guizhou Medical University","Guiyang",{"type":34,"coordinates":83},[84,85],106.71667,26.58333,{"lat":85,"lon":84},{"facility":88,"status":29,"city":89,"state":10,"zip":10,"country":32,"cosmosGeoPoint":90,"geoPoint":94,"contacts":10},"Sir Run Run Shaw Hospital of Zhejiang University School of Medicine","Hangzhou",{"type":34,"coordinates":91},[92,93],120.16142,30.29365,{"lat":93,"lon":92},{"facility":96,"status":29,"city":97,"state":10,"zip":10,"country":32,"cosmosGeoPoint":98,"geoPoint":102,"contacts":10},"QiLu Hospital of ShanDong University","Jinan",{"type":34,"coordinates":99},[100,101],116.99722,36.66833,{"lat":101,"lon":100},{"facility":104,"status":29,"city":105,"state":10,"zip":10,"country":32,"cosmosGeoPoint":106,"geoPoint":110,"contacts":10},"First People's Hospital of Yunnan Province","Kunming",{"type":34,"coordinates":107},[108,109],102.71833,25.03889,{"lat":109,"lon":108},{"facility":112,"status":29,"city":113,"state":10,"zip":10,"country":32,"cosmosGeoPoint":114,"geoPoint":118,"contacts":10},"Affiliated Hospital of Nantong University","Nantong",{"type":34,"coordinates":115},[116,117],120.87472,32.03028,{"lat":117,"lon":116},{"facility":120,"status":29,"city":121,"state":10,"zip":10,"country":32,"cosmosGeoPoint":122,"geoPoint":126,"contacts":10},"Shanxi Cardiovascular Hospital","Taiyuan",{"type":34,"coordinates":123},[124,125],112.56028,37.86944,{"lat":125,"lon":124},{"facility":128,"status":29,"city":129,"state":10,"zip":10,"country":32,"cosmosGeoPoint":130,"geoPoint":134,"contacts":10},"Zhuhai People's Hospital","Zhuhai",{"type":34,"coordinates":131},[132,133],113.56778,22.27694,{"lat":133,"lon":132},{"facility":136,"status":29,"city":137,"state":10,"zip":10,"country":32,"cosmosGeoPoint":138,"geoPoint":142,"contacts":10},"Zigong First People's Hospital","Zigong",{"type":34,"coordinates":139},[140,141],104.77689,29.34162,{"lat":141,"lon":140},{"facility":144,"status":29,"city":145,"state":10,"zip":10,"country":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":10},"Prince of Wales Hospital","Hong Kong",{"type":34,"coordinates":147},[148,149],114.17469,22.27832,{"lat":149,"lon":148},{"facility":152,"status":29,"city":145,"state":10,"zip":10,"country":145,"cosmosGeoPoint":153,"geoPoint":155,"contacts":10},"Princess Margaret Hospital",{"type":34,"coordinates":154},[148,149],{"lat":149,"lon":148},{"facility":157,"status":29,"city":145,"state":10,"zip":10,"country":145,"cosmosGeoPoint":158,"geoPoint":160,"contacts":10},"Queen Mary Hospital",{"type":34,"coordinates":159},[148,149],{"lat":149,"lon":148},{"facility":162,"status":29,"city":163,"state":10,"zip":10,"country":145,"cosmosGeoPoint":164,"geoPoint":168,"contacts":10},"Queen Elizabeth Hospital","Kowloon",{"type":34,"coordinates":165},[166,167],114.18333,22.31667,{"lat":167,"lon":166},{"facility":170,"status":29,"city":171,"state":172,"zip":10,"country":173,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Shonan Kamakura General Hospital","Kamakura-shi","Kanagawa","Japan",{"facility":175,"status":29,"city":176,"state":177,"zip":10,"country":173,"cosmosGeoPoint":178,"geoPoint":182,"contacts":10},"Sendai Kousei Hospital","Sendai","Miyagi",{"type":34,"coordinates":179},[180,181],140.86667,38.26667,{"lat":181,"lon":180},{"facility":184,"status":29,"city":185,"state":186,"zip":10,"country":173,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Kurashiki Central Hospital","Kurashiki-shi","Okayama Kurashiki-shi",{"facility":188,"status":29,"city":189,"state":189,"zip":10,"country":173,"cosmosGeoPoint":190,"geoPoint":194,"contacts":10},"Saitama Red Cross Hospital","Saitama",{"type":34,"coordinates":191},[192,193],139.65657,35.90807,{"lat":193,"lon":192},{"facility":196,"status":29,"city":197,"state":198,"zip":10,"country":173,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Sakakibara Heart Institute, Sakakibara Heart Foundation","Fuchu-shi","Tokyo",{"facility":200,"status":29,"city":201,"state":10,"zip":10,"country":173,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Kokura Memorial Hospital","Fukuoka-ken",{"facility":203,"status":29,"city":172,"state":10,"zip":10,"country":173,"cosmosGeoPoint":204,"geoPoint":208,"contacts":10},"Yokosuka Kyosai Hospital",{"type":34,"coordinates":205},[206,207],139.91667,37.58333,{"lat":207,"lon":206},{"facility":210,"status":29,"city":211,"state":10,"zip":10,"country":173,"cosmosGeoPoint":212,"geoPoint":216,"contacts":10},"Kawasaki Saiwai Hospital","Kawasaki",{"type":34,"coordinates":213},[214,215],139.71722,35.52056,{"lat":215,"lon":214},{"facility":218,"status":29,"city":219,"state":10,"zip":10,"country":173,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Toho University Ohashi Medical Center","Meguro-ku",{"facility":221,"status":29,"city":222,"state":10,"zip":10,"country":173,"cosmosGeoPoint":223,"geoPoint":227,"contacts":10},"Osaka Keisatsu Hospital","Osaka",{"type":34,"coordinates":224},[225,226],135.50107,34.69379,{"lat":226,"lon":225},{"facility":229,"status":29,"city":230,"state":10,"zip":10,"country":173,"cosmosGeoPoint":231,"geoPoint":235,"contacts":10},"Yokohama city minato Red Cross Hospital","Yokohama",{"type":34,"coordinates":232},[233,234],139.65,35.43333,{"lat":234,"lon":233},{"facility":237,"status":29,"city":238,"state":10,"zip":10,"country":239,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Institute Jantung Negara","Kuala Lumpur","Malaysia",{"type":34,"coordinates":241},[242,243],101.68653,3.1412,{"lat":243,"lon":242},[246],{"name":247,"role":23,"phone":10,"phoneExt":10,"email":10},"Surinder Dr.",{"facility":249,"status":29,"city":250,"state":10,"zip":10,"country":239,"cosmosGeoPoint":251,"geoPoint":255,"contacts":10},"Pusat Jantung Sarawak","Kuching",{"type":34,"coordinates":252},[253,254],110.33333,1.55,{"lat":254,"lon":253},{"facility":257,"status":29,"city":258,"state":10,"zip":10,"country":258,"cosmosGeoPoint":259,"geoPoint":263,"contacts":10},"Asian Heart and Vascular Centre","Singapore",{"type":34,"coordinates":260},[261,262],103.85007,1.28967,{"lat":262,"lon":261},{"facility":265,"status":29,"city":266,"state":10,"zip":10,"country":267,"cosmosGeoPoint":268,"geoPoint":272,"contacts":10},"China Medical University Hospital","Taichung","Taiwan",{"type":34,"coordinates":269},[270,271],120.6839,24.1469,{"lat":271,"lon":270},{"facility":274,"status":29,"city":266,"state":10,"zip":10,"country":267,"cosmosGeoPoint":275,"geoPoint":277,"contacts":10},"Taichung Veterans General Hospital",{"type":34,"coordinates":276},[270,271],{"lat":271,"lon":270},{"facility":279,"status":29,"city":280,"state":10,"zip":10,"country":267,"cosmosGeoPoint":281,"geoPoint":285,"contacts":10},"National Taiwan University Hospital","Taipei",{"type":34,"coordinates":282},[283,284],121.52639,25.05306,{"lat":284,"lon":283},{"facility":287,"status":29,"city":280,"state":10,"zip":10,"country":267,"cosmosGeoPoint":288,"geoPoint":290,"contacts":10},"Taipei Veterans General Hospital",{"type":34,"coordinates":289},[283,284],{"lat":284,"lon":283},{"type":292,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100568842",false,"NCT06686485","cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia","OPTION-A","Inclusion Criteria:\n\n1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard of care.\n2. Subjects who are willing and able to provide informed consent.\n3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center.\n4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Subjects who underwent prior AF ablation procedure.\n2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible \u002F non-cardiac causes.\n3. Already surgically closed or otherwise excluded LAA.\n4. The LAA anatomy does not accommodate a Closure Device.\n5. Known or suspected atrial myxoma.\n6. Presence of intracardiac thrombus.\n7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an ASD\u002FPFO device.\n8. Subjects with a presence of a mechanical valve prosthesis in any position.\n9. Subjects with a myocardial infarction within 30 days prior to enrollment.\n10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.\n11. Any planned electrical cardioversion within 30 days following LAAC device implant.\n12. Subjects with a known inability to obtain vascular access.\n13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy), active conditions (e.g. infection, bleeding disorder, unstable angina) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present\\*.\n14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina) are present.\n15. Subjects with any contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.\n16. Subjects who are pregnant or planning to be pregnant.\n17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.\n18. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.","ALL","18 Years",{"count":302,"type":303},433,"ESTIMATED","OBSERVATIONAL","Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.",[307,308,309,310],"Concomitant Procedures","Atrial Fibrillation","PFA","LAAC","2026-06-22",{"date":313,"type":314},"2026-06-25","ACTUAL",{"date":316,"type":314},"2025-03-18",{"date":318,"type":303},"2029-10-31",{"name":5,"class":6},37]