[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100378309":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":52,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":10,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Le Bonheur Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Registry Group",null,"All participants will have the same data collected at the same time points.",[13],"Device: Transcatheter PDA Closure",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Transcatheter PDA Closure","Device utilized for closure of PDA, study is to help assure continued safety and effectiveness of FDA approved Amplatzer Piccolo Occluder device as well as other devices used off label for PDA closure in premature infants less than 2 kg at the time of device implant.",[9],[21],{"name":22,"affiliation":23,"role":24},"Shyam Sathanandam, MD","National Principal Investigator","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Shyam K Sathanandam, MD","CONTACT","901-287-6380","ssathan@uthsc.edu",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"Jorden Cunningham, BSN","901-287-7457","jorden.cunningham@lebonheur.org",[36],{"facility":37,"status":10,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"LeBonheur Children's Hospital","Memphis","Tennessee","38103","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-90.04898,35.14953,{"lat":47,"lon":46},[50,51],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},{"type":24,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Shyam K. Sathanandam, MD","Associate Professor of Pediatrics, University of Tennessee. Director of Cath Lab, Le Bonheur Children's Hospital.",[56],{"name":57,"class":58},"Abbott","INDUSTRY","100378309","the-us-pda-registry-100378309",false,"NCT04205877","The U.S. PDA Registry","The United States Patent Ductus Arteriosus Registry","Inclusion Criteria:\n\n1. Diagnosis of PDA.\n2. Clinical indication for transcatheter PDA closure (discretion of the physician).\n3. Weight \\\u003C2 kg at the time of device implant.\n\nExclusion Criteria:\n\n1. Weight \\\u003C700 gm or greater than or equal to 2 kg at the time of device implant.\n2. Age \\\u003C 3 days at the time of device implant.\n3. Pre-existing coarctation of the aorta.\n4. Pre-existing left pulmonary artery stenosis.\n5. Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension.\n6. Intracardiac thrombus that interferes with device implant.\n7. Active infection requiring treatment at the time of impant.","ALL","3 Days","1 Year",{"count":70,"type":71},5000,"ESTIMATED","OBSERVATIONAL","The objective of this study is to demonstrate the continued safety and efficacy in a real-world setting of transcatheter device closure of the PDA in premature infants less than 2kg in weight at the time of device implant using the Amplatzer Piccolo Occluder device and other devices performed in the USA.",[75],"Ductus Arteriosus, Patent","NOT_YET_RECRUITING","2019-12-17",{"date":79,"type":80},"2019-12-20","ACTUAL",{"date":82,"type":71},"2020-01-01",{"date":84,"type":71},"2031-12-01",{"name":5,"class":6},1]