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NOT YET RECRUITING
NCT07785661
PHASE1/PHASE2

A Study Of Surgical Repair Of Discontinuous Branching Pulmonary Arteries

Sponsor: Joseph Dearani

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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