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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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.
Mayo Clinic
Rochester, Minnesota, United States
Treatment emergent adverse events
Number of participants experiencing treatment-emergent adverse events and serious adverse events after ATEV implantation.
Time frame: 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.
Time frame: 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.
Time frame: 6 months and 12 months post-implantation
Change in Graft Diameter
Change in ATEV graft diameter measured by CT angiography
Time frame: 2 weeks, 3 months, 12 months, and 24 months post-implantation
Change in Graft Length
Change in ATEV graft length measured by CT angiography
Time frame: 2 weeks, 3 months, 12 months, and 24 months post-implantation
Number of Participants With Graft Infection
Number of participants with graft infection
Time frame: 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.
Time frame: Baseline, 4 weeks, 6 months, and 12 months post-implantation
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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.
Time frame: 3 months, 12 months, and 24 months post-implantation