ATEV Conduit for Heart-Lung Connection Repair

CS
Overseen ByCV Surgery Research Team
Age: < 18
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Joseph Dearani
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JD

Joseph Dearani, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

No evidence of pruning, lack of pulmonary artery lung distribution, evidence of focal stenosis, aortopulmonary collaterals or filling defects
Weight greater than 5 kg
Written informed consent obtained from a parent or legal guardian
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Exclusion Criteria

Allergy to bovine proteins
Allergy to aspirin
Platelet count less than 100,000
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What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ATEV Conduit ImplantationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joseph Dearani

Lead Sponsor

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+