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Study no longer needed.
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The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The procedure, tests, medications, and follow-up visits will all be done per standard of care. Medical data will be collected to look at outcomes after surgery.
The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Potential participants are patients 12 and younger with congenital heart defects in need of pulmonary valve replacement.Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The study procedure, tests, medications, and follow-up visits will all be done per standard of care for heart transplant patients. Data will be collected from chart review, before, during and after surgery and at standard of care follow-up visits. Study data will be compared to historical data of patients who have undergone other types of pulmonary valve replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial Heart Transplantation | Experimental | Participants will receive a partial heart transplantation to replace the pulmonary valve with fresh donor graft(s). This is an investigational procedure. This means this procedure is not done as a routine treatment for patients with congenital heart defects. Partial heart transplantation involves surgical replacement of the semilunar heart valve with the heart valve and supporting blood vessels and tissue from an organ donor. No other parts of the heart are transplanted besides the heart valve, blood vessel, and tissue surrounding the valve. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial Heart Transplantation | Procedure | Partial heart transplantation involves surgical replacement of the semilunar heart valve with a fresh donor graft. The surgical procedure (homograft valve replacement) is common and standard of care. The investigational aspect of this is using a freshly procured valve rather than a cryopreserved, cadaveric one and also the use of limited immunosuppression to help maintain the freshly procured valve as "living tissue". |
| Measure | Description | Time Frame |
|---|---|---|
| Number of eligible patients who can be matched for transplant and the tissues needed procured | A measure of feasibility. | Day 1 |
| To assess valve growth following partial heart transplantation. | This will be determined by looking at valve growth compared to body growth over time based on post-operative imaging. | Year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether valve replacement(s) using partial heart transplantation is safe. | This will be determined by survival and major complication rates. | Year 2 |
| To assess valve function following partial heart transplantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Turek, MD, PhD, MBA | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | 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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| Freshly procured valve | Other | Fresh donor graft semilunar heart valve. |
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This will be determined by looking for the development of valve stenosis over time based on post-operative imaging.
| Year 2 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |