A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 1 - 100 |
| Updated: | 4/17/2018 |
| Start Date: | December 2009 |
| End Date: | January 23, 2018 |
An initial feasibility and safety study evaluating the use of autologous tissue engineered
vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in
children with single ventricle anomalies.
vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in
children with single ventricle anomalies.
This investigation is a prospective, nonrandomized phase 1 clinical trial determining the
safety of the use of tissue engineered vascular grafts as conduits for EC TCPC. Primary end
points of the study will include determination of graft failure rates and graft related
morbidity and mortality. Graft failure will be defined as any graft narrowing/occlusion or
dilation/rupture requiring surgical or endovascular intervention. Graft related morbidity and
mortality will include any post-operative complication such as any thromboembolic or
infectious event that requires treatment and is thought likely to be caused by the tissue
engineered vascular graft as determined by the investigators and confirmed by the data safety
monitoring board. All appropriate patients requiring EC TCPC who meet study
inclusion/exclusion criteria will be evaluated for enrollment in the clinical trial. After
obtaining informed consent from the patient's parents, patients with single ventricle cardiac
anomalies will undergo EC TCPC using a tissue engineered conduit. Post-operative care and
monitoring will follow an established, standardized, clinical algorithm in which the
patient's clinical status including complications and measurements of graft function will be
serially evaluated and recorded over a three year period using physical examination,
echocardiography, and MRA.
safety of the use of tissue engineered vascular grafts as conduits for EC TCPC. Primary end
points of the study will include determination of graft failure rates and graft related
morbidity and mortality. Graft failure will be defined as any graft narrowing/occlusion or
dilation/rupture requiring surgical or endovascular intervention. Graft related morbidity and
mortality will include any post-operative complication such as any thromboembolic or
infectious event that requires treatment and is thought likely to be caused by the tissue
engineered vascular graft as determined by the investigators and confirmed by the data safety
monitoring board. All appropriate patients requiring EC TCPC who meet study
inclusion/exclusion criteria will be evaluated for enrollment in the clinical trial. After
obtaining informed consent from the patient's parents, patients with single ventricle cardiac
anomalies will undergo EC TCPC using a tissue engineered conduit. Post-operative care and
monitoring will follow an established, standardized, clinical algorithm in which the
patient's clinical status including complications and measurements of graft function will be
serially evaluated and recorded over a three year period using physical examination,
echocardiography, and MRA.
Inclusion Criteria:
- single ventricle cardiac anomaly requiring extra cardiac total cavopulmonary
connection (EC TCPC).
Exclusion Criteria:
- incomplete inferior vena cava (IVC)
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