Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve (GECT)

Inclusion Criteria: Age ≥ 18 years, Intact appropriate tissue (preferably: Pericardium for pericardiectomy via thoracoscopy or thoracotomy; other option fascia lata, rectus fascia, or diaphragm), Any of the following by transthoracic echocardiography and/or Cardiac Magnet Resonance Imaging: For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR mean systolic gradient across PV or RVOT ≥ 35 mmHg For patients in NYHA Classification I: Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction and/or mean PV or RVOT systolic gradient ≥ 40 mmHg Written informed consent provided by study subjects and/or their parents or legal guardians as approved and required by the respective institutional review board and agrees to its provisions, and obtained before any research related test is performed Exclusion Criteria: Lack of pericardium, or other appropriate tissue Active endocarditis or myocarditis or within 3 months before the screening date Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the ensemble delivery system cannot be advanced to the heart via a transvenous approach from either femoral vein or internal jugular Pre-existing mechanical heart valve in any position Requires emergency surgery Need for concomitant additional mitral and tricuspid valves surgery Recipient of transplanted organs or currently an organ transplant candidate Pulmonary hypertension Connective tissue disorders Coronary artery disease Immunosuppressive disease Estimated survival less than 6 months Fertile females unable to take adequate contraceptive precautions, pregnant, or are currently breastfeeding an infant Acute myocardial infarction within 30 days to the screening date Stroke confirmed by CT, cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months before the screening date Hemodynamic or respiratory instability requiring inotropic or/and mechanical circulatory support, or mechanical ventilation within 30 days before the screening date 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 Renal insufficiency with creatinine level 2.5 mg/dl within 60 days before the screening date Leukopenia with WBC <3.5 x 109/L anemia with Hgb <10 g/dl, or thrombocytopenia with platelet count <50x103/l accompanied by a history of bleeding diathesis or coagulopathy within 60 days before the screening date Adult subject is an illicit drug user, alcohol abuser, prisoner, untreated psychiatry (limited compliance), or unable to give informed consent Clinical Research | ECS - full application | Application template | CR.2-A2 |Mar. 2021 3/25 Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year Inability to comply with all of the study procedures and follow-up visits Patients requiring pre-stenting for dilatation RV outflow greater than 30mm or that a 30mm stent can be used