Absent Pulmonary ArteryPhase 1/2NCT07785661
A Study Of Surgical Repair Of Discontinuous Branching Pulmonary Arteries
A Phase 1/2 study testing Acellular Tissue Engineered Vessel (ATEV) Conduit in people with Absent Pulmonary Artery, run by Joseph Dearani at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Absent Pulmonary Artery
- What is being tested?
- Acellular Tissue Engineered Vessel (ATEV) Conduit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Aug 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic
Rochester, Minnesota, 55905
CV Surgery Research Team, 507-266-9515, CVSURGRESEARCH@mayo.edu
Joseph Dearani, MD
About this study
Official title: Phase 1/2 Clinical Trial of Biologically-engineered Growing Heart Conduit for Repair of Discontinuous Pulmonary Arteries
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.
- Conditions
- Absent Pulmonary Artery
- Being tested
- Acellular Tissue Engineered Vessel (ATEV) Conduit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Tissue Engineered Vessel (ATEV) ConduitBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| ATEV Conduit Implantation | Experimental | Infants with discontinuous pulmonary arteries requiring conduit placement will undergo surgical implantation of one acellular tissue engineered vessel (ATEV) conduit to restore pulmonary blood flow from the main pulmonary artery to the lung. Participants will receive standard-of-care perioperative management and post-implant antithrombotic therapy and will be followed for 24 months after implantation. Receives: Biological: Acellular Tissue Engineered Vessel (ATEV) Conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events
Number of participants experiencing treatment-emergent adverse events and serious adverse events after ATEV implantation.
Measured: 12 months post-implantation
Survival Rate at 6 and 12 Months Post-Implantation
Number of participants alive at 6 and 12 months after ATEV implantation.
Measured: 6 months and 12 months post-implantation
Number of Participants With Graft Failure Requiring Surgical or Angiographic Catheterization Intervention
Number of participants with graft failure requiring surgical intervention or angiographic catheterization after ATEV implantation.
Measured: 6 months and 12 months post-implantation
Change in Graft Diameter
Change in ATEV graft diameter measured by CT angiography
Measured: 2 weeks, 3 months, 12 months, and 24 months post-implantation
Change in Graft Length
Change in ATEV graft length measured by CT angiography
Measured: 2 weeks, 3 months, 12 months, and 24 months post-implantation
Secondary outcomes (3)
Number of Participants With Graft Infection
Number of participants with graft infection
Measured: 6 months and 12 months post-implantation
Change From Baseline in Panel Reactive Antibodies
Change from baseline in panel reactive antibody levels to assess immune response to the graft.
Measured: Baseline, 4 weeks, 6 months, and 12 months post-implantation
Number of Participants With Graft Stenosis or Aneurysm
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.
Measured: 3 months, 12 months, and 24 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absent Pulmonary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph Dearani
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Joseph Dearani, Mayo Clinic
- Investigators
- Joseph Dearani, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785661
- Sponsor's protocol ID
- 25-011690
- Other IDs
- HT9425-25-1-0731
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Clinical Trial of Biologically-engineered Growing Heart Conduit for Repair of Discontinuous Pulmonary Arteries
- ClinicalTrials.gov ID
- NCT07785661
- Acronym / sponsor ID
- 25-011690
- Conditions
- Absent Pulmonary Artery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Joseph DearaniUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATEV Conduit Implantation | Experimental | Biological: Acellular Tissue Engineered Vessel (ATEV) ConduitInfants with discontinuous pulmonary arteries requiring conduit placement will undergo surgical implantation of one acellular tissue engineered vessel (ATEV) conduit to restore pulmonary blood flow from the main pulmonary artery to the lung. Participants will receive standard-of-care perioperative management and post-implant antithrombotic therapy and will be followed for 24 months after implantation. |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acellular Tissue Engineered Vessel (ATEV) ConduitA 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. | Biological | ATEV Conduit Implantation |
Primary outcome
Treatment emergent adverse events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 weeks, 3 months, 12 months, and 24 months post-implantation
Change in ATEV graft diameter measured by CT angiography
Change in Graft Length
Time frame: 2 weeks, 3 months, 12 months, and 24 months post-implantation
Change in ATEV graft length measured by CT angiography
3 secondary outcomes
Number of Participants With Graft Infection
Time frame: 6 months and 12 months post-implantation
Change From Baseline in Panel Reactive Antibodies
Time frame: Baseline, 4 weeks, 6 months, and 12 months post-implantation
Number of Participants With Graft Stenosis or Aneurysm
Time frame: 3 months, 12 months, and 24 months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Dearani, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acellular Tissue Engineered Vessel (ATEV) Conduit in people with Absent Pulmonary Artery, run by Joseph Dearani at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CV Surgery Research Team (507-266-9515, CVSURGRESEARCH@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events (time frame: 12 months post-implantation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.