[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542777":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":54,"collaborators":56,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":10,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"China National Center for Cardiovascular Diseases","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PFO closure",null,"Before PFO closure, all patients will undergo brain DW-MRI. During PFO closure, all patients will undergo right atrial angiography to opacify the PFO, and OCT is used to evaluate the PFO microstructure during angiography while the patient performs the Valsalva maneuver. The presence or absence of in situ thrombus within the PFO will be determined, and thrombus size will be measured. Postoperatively, DW-MRI will be performed 24 hours and one month after the transcatheter closure procedure.",[13],"Device: PFO occluder; ASD occluder",{"label":15,"type":10,"description":16,"interventionNames":17},"ASD closure","Before ASD closure, all patients will undergo brain DW-MRI. After the transcatheter closure of ASD, DW-MRI will be performed 24 hours and one month postoperatively.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","PFO occluder; ASD occluder","Transcatheter closure of atrial septal defect (ASD) and patent foramen ovale (PFO) All cases will be examined with DW-MRI preoperatively, and DW-MRI will be repeated 24 hours and 4 weeks after the transcatheter closure procedure.",[15,9],[25],{"name":26,"affiliation":27,"role":28},"Chaowu Yan, PhD MD","Cardiovascular Institute and Fuwai Hospital","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","13811967138","chaowuyan@163.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Chaowu Yan","RECRUITING","Beijing","Beijing Municipality","100037","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50,53],{"name":51,"role":31,"phone":52,"phoneExt":10,"email":33},"Chaowu Yan, PhD and MD","+861088398408",{"name":51,"role":28,"phone":10,"phoneExt":10,"email":10},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57,60,62,64,66],{"name":58,"class":59},"Beijing Anzhen Hospital","OTHER",{"name":61,"class":59},"The Affiliated Hospital of Xuzhou Medical University",{"name":63,"class":59},"Tibet Autonomous Region People's Hospital",{"name":65,"class":59},"Beijing Tiantan Hospital",{"name":67,"class":59},"Xuanwu Hospital, Beijing","100542777","cerebral-microembolization-associated-with-pfo-closure-100542777",false,"NCT06347276","Cerebral Microembolization Associated With PFO Closure","De Novo Cerebral Microembolization Associated With Patent Foramen Ovale Closure","PFO group\n\nInclusion Criteria:\n\n1\\) age 18 to 65 years; 2) documented PFO with medium-to-large shunts (≥ 20 microbubbles by c-TCD at rest or during the Valsalva maneuver); 3) history of embolic stroke (based on brain magnetic resonance imaging within 24 hours after symptom onset) or TIA within 6 months without other identifiable causes; 4) history of migraine for more than one year without other identifiable causes; 5) asymptomatic group: incidental finding of PFO in asymptomatic individuals, and presence of high-risk activities and\u002For anatomical features related to PFO (high-risk activities were defined as those in which the Valsalva maneuver was performed frequently or those that increased the risk of venous gas formation; and high-risk anatomical features included atrial septal aneurysm and\u002For curtain pattern on c-TCD).\n\nExclusion Criteria:\n\n1\\) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) history of embolic stroke or TIA within the past one month; 3) history of deep vein thrombosis or pulmonary embolism; 4) presence of coronary artery disease and carotid artery lesions; 5) presence of coexistent cardiovascular structural malformations or diseases; 6) allergy to contrast medium; 7) refusal to participate.\n\nASD group\n\nInclusion Criteria:\n\n1\\) age 18 to 65 years; 2) secundum ASD size 10 to 20 mm, with sufficient surrounding rims, except the aortic rim; 3) right heart catheterization: resting SPAP \\\u003C 50 mm Hg, Qp\u002FQs ≥ 1.5 and PVR \\\u003C 5 WU.\n\nExclusion Criteria:\n\n1\\) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) associated with other cardiac abnormalities or diseases; 3) resting SPAP ≥50 mm Hg and resting PVR ≥5 Wood units;4) primum or sinus venosus type ASD; 5) presence of intracardiac thrombi, permanent contraindications to platelet therapy, and allergic reaction to nickel.","ALL","18 Years","65 Years",{"count":79,"type":80},800,"ESTIMATED","OBSERVATIONAL","This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO.",[84,85,86],"Thrombosis Cardiac","Atrial Septal Defect","Patent Foramen Ovale (PFO)",[88],"Patent foramen ovale; stroke; migraine; thrombus","2025-07-20",{"date":91,"type":92},"2025-07-24","ACTUAL",{"date":94,"type":92},"2024-01-01",{"date":96,"type":80},"2026-12-31",{"name":5,"class":6},1]