[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520837":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":24,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Kansas City Heart Rhythm Research Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 - TEE Primary imaging guidance","EXPERIMENTAL","TEE is the primary imaging guidance with 4D ICE is the secondary",[13],"Device: Imaging guidance with TEE and ICE for Left atrial appendage closure",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2 - ICE Primary Imaging Guidance","4D ICE is the primary imaging guidance and TEE is the secondary",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Imaging guidance with TEE and ICE for Left atrial appendage closure","The occluder size for both LAAC devices will be selected based on the maximal diameter of the LAA orifice following the manufacturer guidelines and using the maximal length of the LAA measured on Echocardiogram. Intraprocedural measurements of the LAA width and depth were acquired on both ICE and TEE per protocol. Both ICE and TEE will be used to assess for any procedural complications prior to insertion of the device delivery sheath.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Dhanunjaya Lakkireddy, MD","Kansas City Heart Rhythm Institute","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Donita Atkins","CONTACT","816-651-1969","datkins@kchrf.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Kansas City Heart Rhythm Institute - Roe Clinic","RECRUITING","Overland Park","Kansas","66211","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-94.67079,38.98223,{"lat":49,"lon":48},[52,54],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":53},"Datkins@kchrf.com",{"name":27,"role":29,"phone":24,"phoneExt":24,"email":24},{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100520837","use-of-4d-ice-in-conjunction-with-tee-for-left-atrial-appendage-closure-100520837",false,"NCT06061757","Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure","Use of 4D Intracardiac Echocardiography (4D-ICE) in Conjunction With Transesophageal Echocardiography (TEE) for Left Atrial Appendage Closure (LAAC)","Inclusion Criteria:\n\n* Male\u002FFemales\n* Age:18-80 years\n* History of Atrial Fibrillation\u002FAtrial flutter\n* Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device\n\nExclusion Criteria:\n\n* Inability or unwillingness of an individual to give written informed consent\n* Patient not following with our practice after the procedure\n* Complex anatomy for endocardial LAAC\n* Thrombus in LAA\n* Patients with pericardial effusion in pre-op TEE\u002FCCTA\n* Patients currently pregnant (Serum beta HCG completed when labs obtained for the procedure are completed)","ALL","18 Years","80 Years",{"count":68,"type":69},52,"ESTIMATED","INTERVENTIONAL",[72],"NA","This is a prospective, single center, non-randomized study with two parallel arms intended to study if 4D Intracardiac echocardiography (4D-ICE) (Nuvision, Nuvera TM) will provide better visualization of the anatomical landmarks from the larger imaging volume and provide optimal intra procedural guidance similar to Transesophageal echocardiography (TEE) (GE 6VT-D ULTRASOUND TRANSDUCER) for Left atrial appendage closure (LAAC). The study will enroll approximately 52 subjects and will be followed through 12 months.",[75,76],"Atrial Fibrillation","Stroke","2025-08-27",{"date":79,"type":80},"2025-08-28","ACTUAL",{"date":82,"type":80},"2023-05-10",{"date":84,"type":69},"2025-12-31",{"name":5,"class":6},1]