Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

Inclusion criteria

• Patient requiring RVOT reconstruction, suitable for 16 mm,18 mm, 20 mm and 22 mm valved conduit.
• Male or Female.
• Age > 2 years and < 22 years.
• Right Ventricular to Pulmonary Artery peak gradient > 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both (except for the patients undergoing a Ross procedure)
• The patient, and the patient's parent / legal representative where appropriate, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent by signing the approved informed consent form.
• The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.

Exclusion criteria

• Need for or presence of prosthetic heart valve at other position.
• Need for concomitant surgical procedures (non-cardiac).
• Patients with previously implanted pacemaker (including defibrillators), or mechanical valves.
• Active infection or requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) or viral infection.
• Active endocarditis.
• Leukopenia, defined as White Blood cell Count < than:

• 2-12 years: 5.0 ×103 /μL
• 12 years - Adult:
• Male: 4.5×103 /μL
• Female: 4.5 ×103 /μL
• Acute or chronic anemia, defined as Hemoglobin < than:

• 2-12 years 11.5 g /dl
• 12-18:
• Male: 13 g /dl
• Female 12 g /dl
• Adult:
• Male: 13.5 g /dl
• Female: 12 g /dl Patients can be transfused to meet eligibility criteria
• Thrombocytopenia, defined as Platelet count < than:

• 150,000/mm3 Patients can be transfused to meet eligibility criteria
• Severe chest wall deformity, which would preclude placement of the PV conduit.
• Pulmonary hypertension (≥ half of systemic systolic pressure)
• Right ventricular outflow tract aneurysm.
• Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials. .
• Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs.
• Subject has chronic inflammatory / autoimmune disease.
• Need for emergency cardiac or vascular surgery or intervention.
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.
• Currently participating, or participated within the last 30 days, in an investigational drug or device study.
• Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months.
• Pregnancy.
• Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
• Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.