Absent Pulmonary Artery
Conditions
Brief summary
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.
Interventions
BIOLOGICALAcellular Tissue Engineered Vessel (ATEV) Conduit
A sterile, single-use acellular vascular graft/conduit surgically implanted once to restore pulmonary blood flow from the main pulmonary artery to the lung in infants with discontinuous pulmonary arteries. Participants receive standard perioperative care and post-implant antithrombotic therapy per protocol.
Sponsors
Joseph Dearani
United States Department of Defense
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse events | 12 months post-implantation | Number of participants experiencing treatment-emergent adverse events and serious adverse events after ATEV implantation. |
| Survival Rate at 6 and 12 Months Post-Implantation | 6 months and 12 months post-implantation | Number of participants alive at 6 and 12 months after ATEV implantation. |
| Number of Participants With Graft Failure Requiring Surgical or Angiographic Catheterization Intervention | 6 months and 12 months post-implantation | Number of participants with graft failure requiring surgical intervention or angiographic catheterization after ATEV implantation. |
| Change in Graft Diameter | 2 weeks, 3 months, 12 months, and 24 months post-implantation | Change in ATEV graft diameter measured by CT angiography |
| Change in Graft Length | 2 weeks, 3 months, 12 months, and 24 months post-implantation | Change in ATEV graft length measured by CT angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Graft Infection | 6 months and 12 months post-implantation | Number of participants with graft infection |
| Change From Baseline in Panel Reactive Antibodies | Baseline, 4 weeks, 6 months, and 12 months post-implantation | Change from baseline in panel reactive antibody levels to assess immune response to the graft. |
| Number of Participants With Graft Stenosis or Aneurysm | 3 months, 12 months, and 24 months post-implantation | Number of participants with graft stenosis, defined as greater than 20 mm Hg peak pressure gradient at catheterization, or aneurysm, defined as greater than 1.5 times age-matched diameter, screened by CT angiography. |
Countries
United States
Contacts
CONTACTCV Surgery Research Team
PRINCIPAL_INVESTIGATORJoseph Dearani, MD
Mayo Clinic
Outcome results
None listed