Clinical Trials

Inclusion Criteria:

• Discontinuous pulmonary arteries requiring conduit placement.

• Normal branch pulmonary arteries, with no evidence of hypoplasia or stenosis of distal branches of pulmonary arteries, measured from the hilar pulmonary artery.

• No evidence of pruning, lack of pulmonary artery lung distribution, evidence of focal stenosis, aortopulmonary collaterals or filling defects.

• The proximal portion of the targeted parenchymal pulmonary artery has a minimum diameter of 4mm.

• No history of systemic-pulmonary shunt placement.

• Age 6 months - 2 years (to maximize direct patient benefit).

• Weight >5 kg

• Values within normal range (MN Children’s values, considered universal)

• Participant must have biventricular heart with no hypoplasia of either the left or right ventricle.

• Written informed consent obtained from a parent or legal guardian.

• Caregivers must be willing and able to adhere to protocol requirements, including follow-up visits.

Exclusion Criteria:

• Other congenital cardiac abnormalities that could interfere with graft placement or function

• Allergy to bovine proteins

• Allergy to aspirin

• Platelet count < 100,000

• Extra-cardiac illness that is expected to limit survival to less than 24 months

• Previous operations directly involving the pulmonary arteries and/or a previous median sternotomy.

• Documented coagulations disorders, patients at risk for increased risk of infection (e.g., underlying immunodeficiency including congenital arrythmia), echocardiography evidence of pulmonary hypertension, heparin-induced thrombocytopenia

• Evidence of pruning, lack of pulmonary artery lung distribution, evidence of focal stenosis distal to hilum, aortopulmonary collaterals larger than hilar pulmonary artery diameter or pulmonary artery filling defects

• Children with a low weight for age z score (WAZ) of less than -2.

• Extraordinary obstacles to the ability to follow up regularly include homelessness, parental illness (ongoing medical care, substance abuse, mental illness), or geographical obstacles

• Participation in another clinical trial involving an investigation drug, device, or intervention regardless of potential interference with this study.

• Local or systemic infections will be ruled out by physical exam, vital signs, and a normal white count.

• A period of 2 weeks after treatment of known infection will need to pass prior to having the conduit implanted

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/29/2025. Questions regarding updates should be directed to the study team contact.