This trial is active, not recruiting.

Condition single ventricle cardiac anomaly
Treatment tissue engineered vascular grafts
Phase phase 1
Sponsor Christopher Breuer
Collaborator Doris Duke Charitable Foundation
Start date December 2009
End date December 2018
Trial size 6 participants
Trial identifier NCT01034007, NCHIRB12-00357


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
tissue engineered vascular grafts
Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance angiography (MRA)

Primary Outcomes

graft failure requiring intervention
time frame: 3 years

Secondary Outcomes

graft growth
time frame: 3 years

Eligibility Criteria

Male or female participants from 1 year up to 100 years old.

Inclusion Criteria: - single ventricle cardiac anomaly requiring extra cardiac total cavopulmonary connection (EC TCPC). Exclusion Criteria: - incomplete inferior vena cava (IVC)

Additional Information

Official title A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery
Principal investigator Mark Galantowicz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Nationwide Children's Hospital.