[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597134":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":39,"locations":47,"responsibleParty":64,"collaborators":30,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":30,"enrollmentInfo":76,"targetDuration":30,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":93,"whyStopped":30,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Ultrasound-guided intervention with assistance of specialized instruments group","EXPERIMENTAL","Patients randomized in this group will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments.",[13],"Procedure: Ultrasound-guided intervention with assistance of specialized instruments",{"label":15,"type":16,"description":17,"interventionNames":18},"fluoroscopy-guided intervention group","ACTIVE_COMPARATOR","Patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process",[19],"Procedure: fluoroscopy-guided intervention",{"label":21,"type":6,"description":22,"interventionNames":23},"cohort","Patients meet requirements but have contraindications to fluoroscopy, such as pregnancy, contrast allergy, malignancy, or thyroid dysfunction, are enrolled in the single-arm observational cohort to undergo echocardiography-guided ASD closure assistead by PannaWire",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Ultrasound-guided intervention with assistance of specialized instruments","After detailed evaluation, patients will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments",[9,21],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"fluoroscopy-guided intervention","After detailed evaluation, patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process",[15],[36],{"name":37,"affiliation":5,"role":38},"Fengwen Zhang, MM","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":30,"email":43},"CONTACT","+8688396666","Zhangfengwen08@126.com",{"name":45,"role":41,"phone":42,"phoneExt":30,"email":46},"Ning Zhou","fwzhouning@163.com",[48],{"facility":5,"status":30,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Beijing","Beijing Municipality","100037","China","CN",{"type":55,"coordinates":56},"Point",[57,58],116.39723,39.9075,{"lat":58,"lon":57},[61,63],{"name":37,"role":41,"phone":62,"phoneExt":30,"email":43},"088396666",{"name":37,"role":38,"phone":30,"phoneExt":30,"email":30},{"type":38,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Pan Xiangbin","Principal Investigator","100597134","phase-4-a-novel-echocardiography-guided-strategy-for-percutateous-closure-of-atrial-septal-defect-assisted-by-pannawire-100597134",false,"NCT07054541","A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire","PANNA-ASD","RCT Eligibility Criteria\n\nInclusion Criteria:\n\n* Age ≥ 2 years\n* Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload\n* The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm\n\nExclusion Criteria:\n\n* Pregnant women\n* Contrast agent allergy\n* Renal insufficiency\n* Associated cardiac malformations requiring surgical intervention\n* Right-to-left shunt ASD\n* Ostium primum ASD and sinus venosus ASD\n* Any severe infection within one month before the procedure\n* Intracardiac thrombus\n\nCohort Eligibility Criteria：\n\nInclusion Criteria:\n\n* Age ≥ 2 years\n* Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload\n* The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm\n* Contraindications to radiation exposure or refusal to undergo fluoroscopy-guided procedures\n\nExclusion Criteria:\n\n* Associated cardiac malformations requiring surgical intervention\n* Right-to-left shunt ASD\n* Ostium primum ASD and sinus venosus ASD\n* Any severe infection within one month before the procedure\n* Intracardiac thrombus","ALL","2 Years",{"count":77,"type":78},666,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment. Traditional percutaneous closure procedures are performed under fluoroscopic guidance and require contrast agents. A retrospective analysis of over 20,000 adult patients with congenital heart disease revealed that even low-dose radiation exposure was significantly associated with an increased long-term risk of malignancy. Moreover, the use of contrast agents carries the risk of allergic reactions and kidney injury. Radiation and contrast agents not only pose iatrogenic harm to patients but also limit the use of interventional techniques in special populations, such as pregnant women, patients with contrast agent allergies, or those with renal insufficiency.\n\nTo achieve radiation-free and contrast-free interventional closure procedures, researchers have developed ultrasound-guided percutaneous interventional techniques, yielding satisfactory treatment outcomes. In some cases, these techniques have even enabled cardiovascular procedures to be performed on an outpatient basis, significantly reducing hospitalization time and costs.\n\nThis project proposes a large-sample, multicenter, prospective randomized controlled study to determine whether ultrasound-guided percutaneous intervention for ASD with the assistance of specialized instruments is non-inferior to traditional fluoroscopy-guided procedures, while also offering shorter hospital stays and lower medical expenses.In addition, patients with radiation contraindications or who refuse radiation therapy, and who are willing to undergo ultrasound-guided percutaneous atrial septal defect (ASD) closure with the assistance of dedicated devices, will be enrolled in a separate observational cohort (observational cohort study).",[84],"Atrial Septal Defect (ASD)",[86,87,88,89,90,91,92],"Ultrasound-guided","Percutaneous Intervention","Atrial Septal Defect","Pannawire","PAN Procedure","ASD closure","non fluoroscopic","NOT_YET_RECRUITING","2026-03-14",{"date":96,"type":97},"2026-03-17","ACTUAL",{"date":94,"type":78},{"date":100,"type":78},"2027-10-31",{"name":5,"class":6},1]