Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts

Inclusion Criteria: Candidates for this study must meet all of the following Inclusion criteria: * Age: range from 12-70 years of age * Weight must be "equal to" or exceed 30 kilograms * Subject presents with evidence of moderate or severe (≥3+) pulmonary regurgitation by TTE * Subject presents with \>30% pulmonary regurgitation fraction as defined by cardiac MRI * Subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention: right ventricular ejection fraction (RVEF) \< 45%, pulmonary regurgitant fraction (PRRF) \>30% and increased right ventricular end-diastolic volume (RVEDV) \>150ml/m2 * Subject will comply with specified follow-up evaluations, including echocardiograms and MRI * The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee and regulatory authority if applicable of the respective clinical site * The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits * Catheterization is determined to be feasible by the treating physician Exclusion Criteria: Candidates will be excluded from the study if any of the following conditions are present: * Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) * Severe chest wall deformity * L…