[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659600":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":34,"studyPopulation":35,"armGroups":36,"interventions":30,"overallOfficials":43,"centralContacts":48,"locations":30,"responsibleParty":54,"collaborators":30,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":30,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":30,"enrollmentInfo":67,"targetDuration":30,"studyType":70,"phases":30,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":81,"whyStopped":30,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":30},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Change in systemic oxygen saturation","Mean change in resting systemic oxygen saturation (SpO2) in percentage from baseline to 12 months.","At 12 months",[14,17,20,23,27],{"measure":15,"description":16,"timeFrame":12},"Change in peak RVOT gradient","Mean change in peak right ventricular outflow tract gradient in mmHg measured by echocardiography.",{"measure":18,"description":19,"timeFrame":12},"Change in TAPSE","Mean change in tricuspid annular plane systolic excursion (TAPSE) in millimeters measured by echocardiography.",{"measure":21,"description":22,"timeFrame":12},"Number of patients with improvement in NYHA class","Number of patients showing improvement of at least one New York Heart Association functional class.",{"measure":24,"description":25,"timeFrame":26},"Length of hospital stay","Mean length of hospital stay in days after the index procedure.","At 1 month",{"measure":28,"description":29,"timeFrame":12},"Number of patients requiring reintervention","Number of patients who undergo unplanned reintervention during follow-up.",null,{"allocation":30,"interventionModel":30,"interventionModelDescription":30,"primaryPurpose":30,"observationalModel":32,"timePerspective":33,"maskingInfo":30},"COHORT","PROSPECTIVE","Cyanotic congenital heart disease in adults often involves significant right ventricular outflow tract obstruction. Establishing adequate pulmonary blood flow can be achieved by percutaneous right ventricular outflow tract (RVOT) stenting or surgical right ventricle-to-pulmonary artery (RV-PA) conduit placement.\n\nThis observational study will compare changes in systemic oxygen saturation, echocardiographic parameters, and clinical outcomes between the two treatment approaches in adult patients aged 16 years or older.","Adult patients aged 16 years or older with cyanotic congenital heart disease and significant right ventricular outflow tract obstruction undergoing either percutaneous RVOT stenting or surgical RV-PA conduit placement at Aswan Heart Center.",[37,40],{"label":38,"type":30,"description":39,"interventionNames":30},"Percutaneous RVOT Stenting","Adult patients undergoing percutaneous right ventricular outflow tract stent implantation.",{"label":41,"type":30,"description":42,"interventionNames":30},"Surgical RV-PA Conduit","Adult patients undergoing surgical right ventricle-to-pulmonary artery conduit placement.",[44],{"name":45,"affiliation":46,"role":47},"Yehia T Kishk, prof","Cardiovascular Medicine Department, Assiut University Hospitals","STUDY_CHAIR",[49],{"name":50,"role":51,"phone":52,"phoneExt":30,"email":53},"Fatma A Soliman, Resident","CONTACT","+20 10 70114234","Felkomy12@gmail.com",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Fatma Mohamed Ahmed Soliman","Resident Physician, Department of cardiology","100659600","rvot-stenting-versus-surgical-rv-pa-conduit-in-cyanotic-adults-100659600",false,"NCT07866911","RVOT Stenting Versus Surgical RV-PA Conduit in Cyanotic Adults","Percutaneous Right Ventricular Outflow Tract Stenting Versus Surgical Right Ventricle-to-Pulmonary Artery Conduit Placement in Cyanotic Adults","Inclusion Criteria:\n\n* \\- Age 16 years or older\n* Cyanotic congenital heart disease with significant right ventricular outflow tract obstruction requiring intervention\n* Undergoing either percutaneous RVOT stenting or surgical right ventricle-to-pulmonary artery conduit placement\n* Available baseline clinical, echocardiographic, and cardiac CT data\n* Written informed consent\n\nExclusion Criteria:\n\n* \\- Concomitant major cardiac surgery other than RV-PA conduit placement\n* Contraindications to contrast-enhanced cardiac CT\n* Inadequate CT image quality\n* Incomplete clinical or imaging data\n* Loss to follow-up before planned post-procedural assessment","ALL","16 Years",{"count":68,"type":69},30,"ESTIMATED","OBSERVATIONAL","This prospective observational cohort study aims to compare clinical and hemodynamic outcomes of percutaneous right ventricular outflow tract stenting versus surgical right ventricle-to-pulmonary artery conduit placement in cyanotic adults with congenital heart disease.",[73,74],"Cyanotic Congenital Heart Disease","Right Ventricular Outflow Tract Obstruction",[76,77,78,79,80],"Oxygen saturation","Congenital heart disease","RVOT stenting","RV-PA conduit","Cyanotic adults","NOT_YET_RECRUITING","2026-10-05",{"date":84,"type":85},"2026-10-08","ACTUAL",{"date":87,"type":69},"2026-10-10",{"date":89,"type":69},"2028-01-20",{"name":5,"class":6}]