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This is a prospective, single center, safety and feasibility trial to evaluate the use of autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. Subjects will be identified here at the Advanced Fetal Care Center (AFCC) following diagnosis of congenital heart disease (CHD) with single ventricle physiology of the fetus via fetal echocardiogram. At time of cesarean section or vaginal delivery, umbilical cord will be harvested in a sterile fashion and the umbilical vein will be dissected free and preserved until first clinically indicated Stage I palliative procedure between day 3 and 7 of life. Subjects will be followed until their Stage II palliative procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preserved umbilical vein | Experimental | Preserved umbilical vein as shunt/conduit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preserved umbilical vein as shunt/conduit | Procedure | All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absense of primary serious adverse events | Primary SAEs are defined as:
| from time of insertion to time of Stage II procedure, approximately 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sitaram Emani, MD | Cardiovascular Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |