[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-valve-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-valve-insufficiency":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100266200","compassion-s3---evaluation-of-the-sapien-3-transcatheter-heart-valve-in-patients-with-pulmonary-valve-dysfunction-100266200",false,"NCT02744677","COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction","COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV","Inclusion Criteria:\n\n1. Weight ≥ 20 kg (44 lbs.)\n2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use\n3. Subject presents with at least moderate PR and\u002For mean RVOT gradient ≥ 35 mmHg.\n4. The subject\u002Fsubject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)\n2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days\n3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder\n4. Inappropriate anatomy for femoral introduction and delivery of the study valve\n5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty\n6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)\n7. Interventional\u002Fsurgical procedures within 30 days prior to the TPVI procedure.\n8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.\n9. History of or current intravenous drug use\n10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year\n11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and\u002For antithrombotic medications\n12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated\n13. Participating in another investigational drug or device study that has not reached its primary endpoint.\n14. Female who is lactating or pregnant","ALL",{"count":18,"type":19},108,"ESTIMATED","INTERVENTIONAL",[22],"NA","This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3\u002FSAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.",[25,26,27,28],"Complex Congenital Heart Defect","Dysfunctional RVOT Conduit","Pulmonary Valve Insufficiency","Pulmonary Valve Degeneration",[30,31,32,33,34,35,36,37,38,39,40],"Tetralogy of Fallot","Aortic Valve Defect\u002FDisease Resulting in Ross Procedure","Pulmonary Atresia","Pulmonary Stenosis","Truncus Arteriosus","Transposition of the Great Arteries","Transcatheter pulmonary valve implantation","Transcatheter pulmonary valve replacement","TPV","TPVR","TPVI","RECRUITING","2026-03-04",{"date":44,"type":45},"2026-03-06","ACTUAL",{"date":47,"type":45},"2016-07-05",{"date":49,"type":19},"2031-06",{"name":51,"class":52},"Edwards Lifesciences","INDUSTRY",25,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":20,"phases":66,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100501484","feasibility-study-to-evaluate-the-safety-of-the-autologous-grownvalve-transcatheter-pulmonary-heart-valve-100501484","NCT05809856","Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve","A First-in-Human Feasibility Study to Evaluate the Safety (and Short Term Effectiveness) of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve [GECT]","GECT","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Sufficient appropriate tissue (preferably: Pericardium for pericardiectomy via thoracoscopy or thoracotomy, or sternotomy; other options are fascia lata, rectus fascia, peritoneum or diaphragm)\n3. Any of the following by transthoracic echocardiography and\u002For Cardiac Magnet Resonance Imaging:\n\n   * For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND\u002FOR mean systolic gradient across PV or RVOT ≥ 35 mmHg\n   * For patients in NYHA Classification I: Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction and\u002For mean PV or RVOT systolic gradient ≥ 40 mmHg\n   * Right ventricular ejection fraction (RV-EF): \\\u003C40%.\n   * Right ventricular end-diastolic volume (RVEDV): \\>150 ml\u002Fm2 (body surface area)\n4. Written informed consent provided by study subjects obtained before any research-related test is performed\n\nExclusion Criteria:\n\n* Active endocarditis or myocarditis or within 3 months before the screening date\n* Patients unwilling or unable to provide written informed consent or comply with follow-up requirements\n* Obstruction of the central veins (including the superior and inferior vena cava, and bilateral iliac veins) such that the Ensemble-delivery system\u002F Performer™ - Guiding Sheath\u002F Extra Large Check-Flo® or GORE® DrySeal Flex + Ballon-in-Ballon-catheter cannot be advanced to the heart via a transvenous approach from either femoral vein or internal jugular\n* Requires emergency surgery\n* Recipient of transplanted organs or currently an organ transplant candidate\n* Pulmonary hypertension\n* Connective tissue disorders\n* Coronary artery disease\n* Immunosuppressive disease\n* Estimated survival of less than 6 months\n* Fertile females unable to take adequate contraceptive precautions (PEARL- Index \\\u003C 1%)\n* Females who are pregnant, or are currently breastfeeding an infant\n* Acute myocardial infarction within 30 days of the screening date\n* Stroke confirmed by CT, cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months before the screening date\n* Hemodynamic or respiratory instability requiring inotropic or\u002Fand mechanical circulatory support, or mechanical ventilation within 30 days before the screening date\n* Severe left ventricular systolic dysfunction with ejection fraction ≤ 20% or evidence of an intra-cardiac mass, thrombus, or vegetation assessed by echocardiography before the screening date\n* Renal insufficiency with creatinine level 2.5 mg\u002Fdl within 60 days before the screening date\n* Leukopenia with WBC \\\u003C3.5 x 109\u002FL anemia with Hgb \\\u003C10 g\u002Fdl, or thrombocytopenia with platelet count \\\u003C50x103\u002Fl accompanied by a history of bleeding diathesis or coagulopathy within 60 days before the screening date\n* Adult subject is an illicit drug user, alcohol abuser, or unable to give informed consent\n* Subject is institutionalized by court order or by order of authority (e.g. prisoner, untreated psychiatry; limited compliance)\n* Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than six months Inability to comply with all of the study procedures and follow-up visits\n* Subjects who are dependent on the sponsor or investigators","18 Years","80 Years",{"count":65,"type":19},7,[22],"Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.",[27],[70,71,72,73,74,75,76,77],"Heart Valve Replacement","Pulmonary Valve","Congenital Heart Diseases","Transcatheter Valve","Medical Need","Durable","One-time-solution","Autologous Living Tissue","2025-09-24",{"date":80,"type":45},"2025-09-29",{"date":82,"type":45},"2023-12-18",{"date":84,"type":19},"2031-12-31",{"name":86,"class":87},"Charite University, Berlin, Germany","OTHER",1]