[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501442":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":34,"responsibleParty":96,"collaborators":100,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":18,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":18,"enrollmentInfo":119,"targetDuration":18,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":134,"overallStatus":83,"whyStopped":18,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"UMC Utrecht","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional group","EXPERIMENTAL","Percutaneous intervention for PA stenosis",[13],"Procedure: Percutaneous intervention (stent) for PA stenosis",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Conservative management (percutaneous intervention for PA stenosis 6 months postponed)",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Percutaneous intervention (stent) for PA stenosis","Percutaneous intervention (stent placement) in one or both of the branch pulmonary arteries",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Hans Breur, MD, PhD","CONTACT","+31 88 75 754 59","h.breur@umcutrecht.nl",{"name":32,"role":28,"phone":18,"phoneExt":18,"email":33},"Renée Joosen, MSc","r.s.joosen-2@umcutrecht.nl",[35,54,67,81],{"facility":36,"status":37,"city":38,"state":18,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Amsterdam University Medical Center location AMC","NOT_YET_RECRUITING","Amsterdam","1105 AZ","Netherlands","NL",{"type":43,"coordinates":44},"Point",[45,46],4.88969,52.37403,{"lat":46,"lon":45},[49,52],{"name":50,"role":28,"phone":18,"phoneExt":18,"email":51},"Nico A Blom, MD, PhD","N.A.Blom@amsterdamumc.nl",{"name":53,"role":28,"phone":18,"phoneExt":18,"email":33},"Renée S Joosen, MSc",{"facility":55,"status":37,"city":56,"state":18,"zip":57,"country":40,"countryCode":41,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Leiden University Medical Center","Leiden","2333 ZA",{"type":43,"coordinates":59},[60,61],4.49306,52.15833,{"lat":61,"lon":60},[64,66],{"name":50,"role":28,"phone":18,"phoneExt":18,"email":65},"N.A.Blom@lumc.nl",{"name":53,"role":28,"phone":18,"phoneExt":18,"email":33},{"facility":68,"status":37,"city":69,"state":18,"zip":70,"country":40,"countryCode":41,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Erasmus Medical Center","Rotterdam","3015 CN",{"type":43,"coordinates":72},[73,74],4.47917,51.9225,{"lat":74,"lon":73},[77,80],{"name":78,"role":28,"phone":18,"phoneExt":18,"email":79},"Thomas B Krasemann, MD, PhD","t.krasemann@erasmusmc.nl",{"name":53,"role":28,"phone":18,"phoneExt":18,"email":33},{"facility":82,"status":83,"city":84,"state":18,"zip":85,"country":40,"countryCode":41,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"UMC Utrecht\u002FWKZ","RECRUITING","Utrecht","3584 CX",{"type":43,"coordinates":87},[88,89],5.12222,52.09083,{"lat":89,"lon":88},[92,95],{"name":93,"role":28,"phone":94,"phoneExt":18,"email":30},"Johannes MPJ Breur, MD, PhD","0031887575459",{"name":53,"role":28,"phone":18,"phoneExt":18,"email":33},{"type":97,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Hans Breur","Dr.",[101,103,106,107,108],{"name":102,"class":6},"Dutch Heart Foundation",{"name":104,"class":105},"Hartekind","UNKNOWN",{"name":68,"class":6},{"name":55,"class":6},{"name":109,"class":6},"Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)","100501442","effects-branch-pa-stenting-d-tga-tof-and-ta-100501442",false,"NCT05809310","Effects Branch PA Stenting d-TGA, ToF and TA","The Effects of Branch Pulmonary Artery Stenting in d-TGA, ToF and TA: a Randomized Control Trial","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Patients with d-TGA post ASO, ToF or TA\n* ≥8 years\n\nExclusion Criteria:\n\nOne or more of the following inclusion criteria:\n\n* All class IIa indications for a branch PA intervention:\n* Persistent decreased RV function (based on gold standard CMR)\n\n  * \\\u003C18 years RVEF ≤55% (28)\n  * ≥18 years RVEF\\\u003C50% (29)\n* Progressive tricuspid regurgitation (TR) (≥moderate)\n* Isolated bifurcation stenosis:\n\n  * Significant unilateral stenosis (≥50%)\n  * Borderline bilateral PA stenosis (40-70%)\n* Unbalanced perfusion (≤35\u002F65%)\n* RV\u002FLV pressure ratio \\> 2\u002F3 based on echocardiography\n* Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET)\n\n  * \\\u003C18 years VO2 peak \\\u003C35 mL∙kg-1∙min-1 (boys) VO2 peak \\\u003C30 mL∙kg-1∙min-1 (girls) (30)\n  * ≥18 years VO2 peak \\\u003C27 mL∙kg-1∙min-1 (men) VO2 peak \\\u003C19 mL∙kg-1∙min-1 (women) (31)","ALL","8 Years",{"count":120,"type":121},56,"ESTIMATED","INTERVENTIONAL",[124],"NA","The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA.\n\nThe main question\\[s\\] it aims to answer are:\n\nThe primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions.\n\nParticipants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht\u002FWKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions.\n\nResearchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)",[127,128,129,130,131,132,133],"Transposition of Great Vessels","Tetralogy of Fallot","Truncus Arteriosus","Pulmonary Artery Stenosis Supravalvular Congenital","Stent Stenosis","Right Ventricular Dysfunction","Congenital Heart Disease",[135],"Exercise capacity","2025-03-25",{"date":138,"type":139},"2025-03-30","ACTUAL",{"date":141,"type":139},"2023-04-18",{"date":143,"type":121},"2027-12-31",{"name":5,"class":6},4]