Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts

ConditionsHLH - Hypoplastic Left Heart Syndrome DORV DILV - Double Inlet Left Ventricle Mitral Atresia Tricuspid Atresia Unbalanced AV Canal Single-ventricle Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorNationwide Children's Hospital

About this trial

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

Eligibility criteria

Qualifiers

Patients will be eligible for inclusion in the study if they meet all of the following criteria.

Patient must be a candidate to undergo an extracardiac total cavopulmonary connection.

Patient and/or legal guardian must voluntarily provide informed consent/assent for participation in the study.

Disqualifiers

Patients will be excluded from participation in the study if they meet any of the following criteria.

Patient has an urgent/emergent operative status.

Patient has acute renal failure or renal insufficiency in the opinion of the investigator

Patient requires a graft less than 12 mm or greater than 24 mm in diameter.

Trial design

Treatments tested in this trial

Tissue Engineered Vascular Grafts

Treatment groups

24 Participants

are divided into 1 treatment group

Sponsors and collaborators

Nationwide Children's Hospital

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Gunze Limited

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov