A graft that grows? new vessel may spare infants repeat surgeries
NCT ID NCT07785661
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This trial tests a new type of blood vessel graft, called ATEV, in infants born with a missing or disconnected pulmonary artery. The graft is designed to reconnect the heart to the lungs and grow as the child grows, potentially avoiding future surgeries. The study will evaluate safety, survival, and how well the graft performs over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Acellular Tissue Engineered Vessel (ATEV) Conduit
- What this could lead to
- If successful, this graft could provide a one-time fix that grows with the child, potentially eliminating the need for multiple future surgeries.
- What could go wrong
- This is an early-phase trial with only 6 infants, so safety and effectiveness are not yet proven. Risks include graft failure, infection, or immune response.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Oct 2026
An estimate. Start dates often move.
- Expected to finish
-
Aug 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 months to 2 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Absent pulmonary artery are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Mayo Clinic
Rochester, Minnesota, 55905, United States