ATEV Conduit for Heart-Lung Connection Repair
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?
Joseph Dearani, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for infants aged 6 months to 2 years with a specific heart-lung blood vessel problem (discontinuous pulmonary arteries) who need surgery. Children must weigh over 5 kg, have normal heart and lung artery structure, no major infections or allergies to certain proteins or aspirin, and be able to attend follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Implantation
Infants undergo surgical implantation of the ATEV conduit to restore pulmonary blood flow
Post-implantation Monitoring
Participants receive standard-of-care perioperative management and post-implant antithrombotic therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acellular Tissue Engineered Vessel (ATEV) Conduit
Trial Overview
The study tests a new artificial blood vessel (ATEV conduit) designed to connect the heart and lungs in young children. The graft aims to grow as the child grows, possibly reducing future surgeries. Researchers are checking its safety and how well it works after surgical placement.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Infants with discontinuous pulmonary arteries requiring conduit placement will undergo surgical implantation of one acellular tissue engineered vessel (ATEV) conduit to restore pulmonary blood flow from the main pulmonary artery to the lung. Participants will receive standard-of-care perioperative management and post-implant antithrombotic therapy and will be followed for 24 months after implantation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joseph Dearani
Lead Sponsor
United States Department of Defense
Collaborator
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