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A Study Of Surgical Repair Of Discontinuous Branching Pulmonary Arteries
Sponsor: Joseph Dearani
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.
Official title: 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
Key Details
Gender
All
Age Range
6 Months - 2 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2026-10-01
Completion Date
2030-08-31
Last Updated
2026-08-25
Healthy Volunteers
No
Conditions
Interventions
Acellular 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.
Locations (1)
Mayo Clinic
Rochester, Minnesota, United States