[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501484":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":57,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":20,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Implantation of autologous GrOwnValve","EXPERIMENTAL","Implantation of autologous GrOwnValve via minimal-invasive transcatheter technique into patients with high-grade pulmonary valve insufficiency and right ventricular dilatation.",[13],"Device: GrOwnValve - novel heart valve replacement approach",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","GrOwnValve - novel heart valve replacement approach","The autologous GrOwnValve is implanted into a stent before it is implanted via minimal-invasive transcatheter technique into the patients with high-grade pulmonary valve insufficiency and right ventricular dilatation. Control intervention\u002FReference test: Since the study is designed for investigating the safety of the procedure, there will not be a control group. However, the outcomes will be compared as a non-inferiority analysis with the standard of current medical care (Edwards SAPIEN 3 or Medtronic's Melody, both bioprosthetic transcatheter pulmonary valves).",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Boris Schmitt, Dr.","Charité UNiveristätsmedizin Berlin, Deutsches Herzzentreum der Charité","STUDY_DIRECTOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+49 30 4593 2846","boris.schmitt@charite.de",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Frank Edelmann, Prof. Dr.","+49 30 450 553731","frank.edelmann@charite.de",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Deutsches Herzzentrum der Charité","RECRUITING","Berlin","State of Berlin","13353","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],13.41053,52.52437,{"lat":48,"lon":47},[51,54],{"name":52,"role":28,"phone":20,"phoneExt":20,"email":53},"Svenja Broschag, MSc","svenja.broschag@dhzc-charite.de",{"name":55,"role":28,"phone":20,"phoneExt":20,"email":56},"Marvin Steitz, MSc","marvin.steitz@dhzc-charite.de",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Univ.-Prof. Dr. med. Frank Edelmann","Univ.-Prof. Dr. med.",[62],{"name":63,"class":64},"GrOwnValve GmbH","UNKNOWN","100501484","feasibility-study-to-evaluate-the-safety-of-the-autologous-grownvalve-transcatheter-pulmonary-heart-valve-100501484",false,"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","ALL","18 Years","80 Years",{"count":77,"type":78},7,"ESTIMATED","INTERVENTIONAL",[81],"NA","Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.",[84],"Pulmonary Valve Insufficiency",[86,87,88,89,90,91,92,93],"Heart Valve Replacement","Pulmonary Valve","Congenital Heart Diseases","Transcatheter Valve","Medical Need","Durable","One-time-solution","Autologous Living Tissue","2025-09-24",{"date":96,"type":97},"2025-09-29","ACTUAL",{"date":99,"type":97},"2023-12-18",{"date":101,"type":78},"2031-12-31",{"name":5,"class":6},1]