[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648562":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":10,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":10,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":56,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Yonsei University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Retrospective cohort",null,"Patients aged 19 years or older who underwent percutaneous patent foramen ovale closure between 2010 and March 2026 and had at least one post-procedural agitated saline transthoracic echocardiography. Approximately 140 patients. Data are obtained by review of electronic medical records under a waiver of informed consent.",{"label":13,"type":10,"description":14,"interventionNames":10},"Prospective registry cohort","Group\u002FCohort Description: Patients aged 19 years or older who undergo percutaneous patent foramen ovale closure after institutional review board approval, provide written informed consent, and are followed prospectively for up to 119 months.",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Jung-Sun Kim, Professor","CONTACT","+82-2-2228-8335","kjs1218@yuhs.ac",[22],{"facility":23,"status":24,"city":25,"state":10,"zip":10,"country":26,"countryCode":10,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Yonsei University College of Medicine","RECRUITING","Seoul","South Korea",{"type":28,"coordinates":29},"Point",[30,31],126.9784,37.566,{"lat":31,"lon":30},[34],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100648562","long-term-outcomes-after-percutaneous-patent-foramen-ovale-closure-severance-pfo-registry-100648562",false,"NCT07724171","Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)","Long-term Clinical Outcomes and Prognostic Factors After Percutaneous Patent Foramen Ovale Closure: A Retrospective Cohort Study With Prospective Registry Extension","Inclusion Criteria:\n\n1. Age 19 years or older\n2. Percutaneous patent foramen ovale closure\n3. Retrospective cohort: closure performed between 2010 and March 2026, with at least one post-procedural agitated saline transthoracic echocardiography\n4. Prospective cohort: closure performed after institutional review board approval, with written informed consent\n\nExclusion Criteria:\n\n1. Atrial septal defect closure (defect other than patent foramen ovale)\n2. Device embolization or device removal\n3. Echocardiographic image quality inadequate for assessment of shunt\n4. Prospective cohort: refusal of informed consent","ALL","19 Years",{"count":47,"type":48},400,"ESTIMATED","OBSERVATIONAL","Patent foramen ovale (PFO) is a congenital interatrial communication present in about one quarter of the general population and is recognized as a major cause of cryptogenic stroke. Percutaneous PFO closure reduces recurrent stroke, but a residual right-to-left shunt persists in 20 to 40 percent of patients after device implantation. Long-term data on device performance, the evolution of residual shunt over time, new-onset atrial fibrillation and other prognostic factors remain limited.\n\nThis single-center registry evaluates the long-term efficacy and safety of percutaneous PFO closure and identifies the clinical, anatomical, procedural and pharmacological factors associated with clinical and echocardiographic outcomes. The registry combines a retrospective cohort of patients treated at Severance Hospital between 2010 and March 2026 with a prospective registry extension that enrolls patients undergoing PFO closure after institutional review board approval, with follow-up for up to 119 months.\n\nClinical outcomes include recurrent ischemic stroke or transient ischemic attack, all-cause death, device-related complications and new-onset atrial fibrillation. Echocardiographic outcomes are assessed by serial agitated saline transthoracic echocardiography, which allows the presence, grade and longitudinal trajectory of residual shunt to be characterized.",[52,53,54,55],"Patent Foramen Ovale","Cryptogenic Stroke","Transient Ischemic Attack Due to Embolism","Atrial Fibrillation",[57,58,59,60,61,62,63,64,65,66],"patent foramen ovale (PFO)","percutaneous closure","residual shunt","right-to-left shunt","agitated saline contrast echocardiography","transthoracic echocardiography (TTE)","recurrent stroke","transient ischemic attack (TIA)","registry","prognostic factors","2026-07-21",{"date":69,"type":70},"2026-07-23","ACTUAL",{"date":72,"type":70},"2026-06-05",{"date":74,"type":48},"2036-05-04",{"name":5,"class":6},1]