[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atrial-septal-defect-asd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atrial-septal-defect-asd":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":19,"type":20},666,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26],"Atrial Septal Defect (ASD)",[28,29,30,31,32,33,34],"Ultrasound-guided","Percutaneous Intervention","Atrial Septal Defect","Pannawire","PAN Procedure","ASD closure","non fluoroscopic","NOT_YET_RECRUITING","2026-03-14",{"date":38,"type":39},"2026-03-17","ACTUAL",{"date":36,"type":20},{"date":42,"type":20},"2027-10-31",{"name":44,"class":45},"Chinese Academy of Medical Sciences, Fuwai Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100569894","lifetech-acumark-sizing-balloon-post-market-clinical-follow-up-study-100569894","NCT06700174","Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study","A Multicenter, Prospective, Single-arm, Observational Study","Inclusion Criteria:\n\n1. Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;\n2. The anatomy of ASD is suitable for percutaneous closure;\n3. Patients are scheduled to perform ASD closure;\n4. Patients or legally authorized representative(s) who are willing and capable of providing informed consent.\n\nExclusion Criteria:\n\n1. Any contraindication for ASD closure;\n2. Patients have ostium primum ASD or coronary sinus ASD;\n3. Patients who are pregnant or breastfeeding;\n4. Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.",{"count":55,"type":20},100,"OBSERVATIONAL","The objective of this PMCF study is to:\n\n* confirm the safety and performance of the AcuMarkTM Sizing Balloon\n* identify previously unknown side-effects\n* monitor the identified side-effects (related to the procedure or to the medical devices)",[26],"RECRUITING","2024-11-19",{"date":62,"type":39},"2024-11-21",{"date":64,"type":39},"2024-09-24",{"date":66,"type":20},"2025-03-31",{"name":68,"class":69},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",5,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":46},"100564619","phase-4-effect-of-dexmedetomidine-supplementation-to-general-anaesthesia-in-paediatric-transcatheter-closure-of-atrial-septal-defect-100564619","NCT06631534","Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect","Inclusion Criteria:\n\n* Pediatric Patients 3-12 years of age admitted for device closure of ASD secundum\n\nExclusion Criteria:\n\n* ASA IV, V\n* Neurological problems (cerebral palsy, mental retardation, etc.,)\n* Children with chromosomal abnormalities or other multiple congenital anomalies or other complex cardiac anomalies\n* Hepatic or renal insufficiency\n* History of allergy to the drugs used\n* Previous Cardiac Surgery","3 Years","12 Years",{"count":80,"type":20},30,[23],"The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters. Additionally he stress reducing effects of dexmedetomidine will be investigated in this population .\n\nThe main questions it aims to answer are:\n\nDoes Dexmedetomidine maintain stable hemodynamics in pediatric patients undergoing transcatheter ASD Closure while improving their quality of recovery?\n\nDoes dexmedetomidine prolong duration of recovery and time to extubation in pediatric patients ?\n\nDoes dexmedetomidine exert stress reducing properties in this population?\n\nParticipants will:\n\nEither be administered Dexmedetomidine in a loading\u002Fmaintenance regimen or a placebo, with hemodynamics being monitored at the baseline, intraoperatively and postoperatively, with recovery time and quality of recovery especially emergence delirium being monitored. Stress hormone levels will be sampled at baseline and postoperatively.",[26,84,85,86],"Dexmedetomidine","Delirium - Postoperative","Stress Response",[88,89,84,90,91,92,93,94,95],"Atrial septal Defect","ASD","Echocardiography","Cardiac index","PAED","VTI","Norepinephrine","Corisol","2024-10-10",{"date":98,"type":39},"2024-10-15",{"date":100,"type":39},"2024-04-03",{"date":102,"type":20},"2024-12",{"name":104,"class":45},"Alexandria University"]