[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"failure-of-fontan-type-circulation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:failure-of-fontan-type-circulation":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100633875","occlutech-afr-fontan-study-100633875",false,"NCT07532369","Occlutech AFR Fontan Study","Clinical Experience With the Occlutech Atrial Flow Regulator (Occlutech AFR) in a Failing Fontan Population","Inclusion Criteria:\n\n* The patient has been treated with an AFR device (attempted or successful) for failing Fontan through the Expanded Access Program of the Food and Drug Administration (FDA).\n* The candidate\u002Fcandidate's legal guardian has been informed of the nature of the study, agrees to its provisions and has provided written informed consent unless the site's IRB provided a waiver of consent.\n\nExclusion Criteria:\n\n* If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included","ALL",{"count":18,"type":19},25,"ESTIMATED","OBSERVATIONAL","The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation. This study will consist of a case series of congenital patients with Fontan failure who have been treated with an Occlutech AFR under the FDA's Expanded Access process.\n\nThe scope of this study is to gain clinical experience on the Occlutech AFR in Fontan failure patients. Cases in this study will be evaluated to evaluate the safety and effectiveness of the device.\n\nThe objective of this study is to evaluate the Occlutech AFR with respect to device safety and shunt patency at 1 year. Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.",[23,24,25,26],"Failure of Fontan Type Circulation","Fenestration","Univentricular Heart","Congenital Anomaly","NOT_YET_RECRUITING","2026-04-08",{"date":30,"type":31},"2026-04-15","ACTUAL",{"date":33,"type":19},"2026-05-01",{"date":35,"type":19},"2026-09",{"name":37,"class":38},"Occlutech International AB","INDUSTRY",7]