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A Study Of Surgical Repair Of Discontinuous Branching Pulmonary Arteries

NCT07785661 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-08-25

No results posted yet for this study

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.

Conditions

  • Absent Pulmonary Artery

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Joseph Dearani

    lead OTHER

Principal Investigators

  • Joseph Dearani, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2030-08-31
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785661 on ClinicalTrials.gov