A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery

NCT ID: NCT01034007

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2018-01-23

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.

Conditions

Single Ventricle Cardiac Anomaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tissue Engineered Vascular Grafts

Group Type: EXPERIMENTAL

Tissue Engineered Vascular Grafts

Intervention Type: COMBINATION_PRODUCT

Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance angiography (MRA)

Interventions

Tissue Engineered Vascular Grafts

Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance angiography (MRA)

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• incomplete inferior vena cava (IVC)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Doris Duke Charitable Foundation

OTHER

Sponsor Role: collaborator

Gunze Limited

OTHER

Sponsor Role: collaborator

Christopher Breuer

OTHER

Sponsor Role: lead

Responsible Party

Christopher Breuer

Director of Tissue Engineering

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christopher K Breuer, MD

Role: STUDY_CHAIR

Nationwide Children's Hospital, Columbus, Ohio

Toshiharu Shinoka, MD/PhD

Role: STUDY_CHAIR

Nationwide Children's Hospital, Columbus, Ohio

Mark Galantowicz, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

NCHIRB12-00357

Identifier Type: -

Identifier Source: org_study_id