Clinical trial NCT01034007: A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery
Official title: A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Single Ventricle Cardiac Anomaly
Keywords: tissue engineered vascular graft
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
name: Gunze Limited
First posted: 2009-12-17
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* single ventricle cardiac anomaly requiring extra cardiac total cavopulmonary connection (EC TCPC).

Exclusion Criteria:

* incomplete inferior vena cava (IVC)

Primary outcomes:
measure: graft failure requiring intervention
timeFrame: 3 years
Secondary outcomes:
measure: graft growth
timeFrame: 3 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital, Columbus, Ohio
name: Christopher K Breuer, MD
role: STUDY_CHAIR
affiliation: Nationwide Children's Hospital, Columbus, Ohio
name: Toshiharu Shinoka, MD/PhD
role: STUDY_CHAIR
affiliation: Nationwide Children's Hospital
name: Mark Galantowicz, MD
role: PRINCIPAL_INVESTIGATOR
References: