A Study Of Surgical Repair Of Discontinuous Branching Pulmonary Arteries

A Phase 1/2, Open-Label Clinical Trial To Assess The Safety Of The Acellular Vascular Graft ATEV In Infants With Discontinuous Pulmonary Arteries Requiring Conduit Placement

The purpose of this study is to test the safety and performance of a new blood vessel graft, called the ATEV. The graft is designed to reconnect the heart to the lungs and to grow as the child grows, which may eliminate the need for future surgeries.

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