[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585788":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":203,"collaborators":20,"id":205,"slug":206,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":20,"eligibilityCriteria":211,"healthyVolunteers":207,"sex":212,"minAge":20,"maxAge":20,"enrollmentInfo":213,"targetDuration":20,"studyType":216,"phases":217,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},{"fullName":5,"class":6},"Medtronic Cardiovascular","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment","OTHER","The Harmony TPV implant as per Standard of Care",[13],"Radiation: Certain imaging assessments can be non-Standard of Care",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Certain imaging assessments can be non-Standard of Care","Pre-Implant CT, Chest X-Ray at discharge and any related assessments during the following up visit, can be non-standard of care depending on site's \u002F countries.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Peter Ewert, Prof. Dr.","TUM Klinikum Deutsches Herzzentrum","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Petra Novakova","CONTACT","+31612591883","rs.harmonyemeapms@medtronic.com",[33,49,64,78,91,104,115,130,145,161,173,188],{"facility":34,"status":35,"city":36,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Rigshospitalet","RECRUITING","Copenhagen","Denmark","DK",{"type":40,"coordinates":41},"Point",[42,43],12.56553,55.67594,{"lat":43,"lon":42},[46],{"name":47,"role":29,"phone":20,"phoneExt":20,"email":48},"Michael Rahbek Schmidt, Dr.","michael.rahbek.schmidt@regionh.dk",{"facility":50,"status":35,"city":51,"state":20,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque","Bordeaux","33600","France","FR",{"type":40,"coordinates":56},[57,58],-0.58046,44.84124,{"lat":58,"lon":57},[61],{"name":62,"role":29,"phone":20,"phoneExt":20,"email":63},"Jean-Benoit Thambo, Dr.","jean-benoit.thambo@chu-bordeaux.fr",{"facility":65,"status":35,"city":66,"state":20,"zip":20,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Herz - und Diabeteszentrum NRW","Bad Oeynhausen","Germany","DE",{"type":40,"coordinates":70},[71,72],8.80365,52.20699,{"lat":72,"lon":71},[75],{"name":76,"role":29,"phone":20,"phoneExt":20,"email":77},"Stephan Schubert, Prof. Dr.","sschubert@hdz-nrw.de",{"facility":79,"status":35,"city":80,"state":20,"zip":81,"country":67,"countryCode":68,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Charité - Universitätsmedizin Berlin","Berlin","12203",{"type":40,"coordinates":83},[84,85],13.41053,52.52437,{"lat":85,"lon":84},[88],{"name":89,"role":29,"phone":20,"phoneExt":20,"email":90},"Peter Kramer, Dr.","peter.kramer@dhzc-charite.de",{"facility":92,"status":35,"city":93,"state":20,"zip":94,"country":67,"countryCode":68,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Helios Health Institute Standort Leipzig","Leipzig","04289",{"type":40,"coordinates":96},[97,98],12.37129,51.33962,{"lat":98,"lon":97},[101],{"name":102,"role":29,"phone":20,"phoneExt":20,"email":103},"Ingo Dähnert, Prof. Dr.","Ingo.Daehnert@helios-gesundheit.de",{"facility":105,"status":35,"city":106,"state":20,"zip":20,"country":67,"countryCode":68,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"TUM University Hospital","Munich",{"type":40,"coordinates":108},[109,110],11.57549,48.13743,{"lat":110,"lon":109},[113],{"name":23,"role":29,"phone":20,"phoneExt":20,"email":114},"ewert@dhm.mhn.de",{"facility":116,"status":35,"city":117,"state":20,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Mater Misericordiae University Hospital","Dublin","7","Ireland","IE",{"type":40,"coordinates":122},[123,124],-6.24889,53.33306,{"lat":124,"lon":123},[127],{"name":128,"role":29,"phone":20,"phoneExt":20,"email":129},"Damien Kenny, Prof. Dr.","Damien.Kenny@childrenshealthireland.ie",{"facility":131,"status":35,"city":132,"state":20,"zip":133,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Schneider Children's Medical Center Israel","Petah Tikva","49202","Israel","IL",{"type":40,"coordinates":137},[138,139],34.88747,32.08707,{"lat":139,"lon":138},[142],{"name":143,"role":29,"phone":20,"phoneExt":20,"email":144},"Einat Birk, Prof.","ebirk@clalit.org.il",{"facility":146,"status":147,"city":148,"state":20,"zip":149,"country":150,"countryCode":151,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Policlinico di Sant'Orsola","NOT_YET_RECRUITING","Bologna","40138","Italy","IT",{"type":40,"coordinates":153},[154,155],11.33875,44.49381,{"lat":155,"lon":154},[158],{"name":159,"role":29,"phone":20,"phoneExt":20,"email":160},"Andrea Donti, Dr.","andrea.donti@aosp.bo.it",{"facility":162,"status":147,"city":163,"state":20,"zip":20,"country":150,"countryCode":151,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Azienda Ospedaliera di Padova","Padova",{"type":40,"coordinates":165},[166,167],11.14261,44.38225,{"lat":167,"lon":166},[170],{"name":171,"role":29,"phone":20,"phoneExt":20,"email":172},"Biagio Castaldi, Prof.","biagio.castaldi@aopd.veneto.it",{"facility":174,"status":35,"city":175,"state":20,"zip":176,"country":177,"countryCode":178,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Hospital General Universitario Gregorio Marañón","Madrid","28007","Spain","ES",{"type":40,"coordinates":180},[181,182],-3.70256,40.4165,{"lat":182,"lon":181},[185],{"name":186,"role":29,"phone":20,"phoneExt":20,"email":187},"Ricardo Sanz, Dr.","ricardo.sanz@salud.madrid.org",{"facility":189,"status":35,"city":190,"state":20,"zip":191,"country":192,"countryCode":193,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Skånes Universitetssjukhus Lund","Lund","22185","Sweden","SE",{"type":40,"coordinates":195},[196,197],13.19321,55.70584,{"lat":197,"lon":196},[200],{"name":201,"role":29,"phone":20,"phoneExt":20,"email":202},"Petru Liuba, Prof.","petru.liuba@med.lu.se",{"type":204,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100585788","harmony-tpv-emea-pms-100585788",false,"NCT06906926","Harmony TPV EMEA PMS","Harmony TPV EMEA Post-Market Study","Inclusion Criteria:\n\n1. Subject eligible to receive Harmony TPV System in conformity with Instructions for Use (IFU) and local regulations at time of study enrollment.\n2. Subject or subject's parent(s)\u002Flegal guardian(s) must be willing and able to consent to participate in the study and will commit to completion of all follow-up requirements\n\nExclusion Criteria:\n\n1. Obstruction of the central veins.\n2. Planned concomitant branch pulmonary artery stenting at time of implant.\n3. Subjects previously treated with an RV-PA conduit or previously implanted bioprosthesis.\n4. A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year.\n5. Planned implantation of the Harmony TPV in the left heart.\n6. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n7. Pre-existing prosthetic heart valve or prosthetic ring in any position\n8. Subject is pregnant as confirmed by a positive pregnancy test before implant procedure for female subjects of childbearing potential.\n9. Subjects that are vulnerable as defined in the Section 10.5 Subject Consent\n\nSubject Consent Section excerpt:\n\n* Vulnerable adults, defined as subjects incapable of giving consent, as assessed per Investigator's opinion and in consideration of vulnerable adult definition per ISO 14155, will not be included in this study.\n* Any subject with mental incompetence (e.g. Alzheimer's, dementia, psychiatric disorders, developmental disorders, chromosomal abnormalities with associated cognitive impairment) should be assessed by the Investigator for vulnerable status. If pediatric or adult subject is deemed by the Investigator mentally incompetent as described above, the subject will not be included in this study.","ALL",{"count":214,"type":215},80,"ESTIMATED","INTERVENTIONAL",[218],"NA","The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and\u002For pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement as judged by the medical team.",[221],"Severe Pulmonary Valve Regurgitation",[223,224,225],"Harmony TPV","severe pulmonary regurgitation","pulmonary valve replacement","2026-05-04",{"date":228,"type":229},"2026-05-05","ACTUAL",{"date":231,"type":229},"2025-07-30",{"date":233,"type":215},"2032-12-31",{"name":5,"class":6},12]