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

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ClinicalTrials.gov Identifier: NCT01034007
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : March 2, 2018
Sponsor:
Collaborators:
Doris Duke Charitable Foundation
Gunze Limited
Information provided by (Responsible Party):
Christopher Breuer, Nationwide Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Single Ventricle Cardiac Anomaly Combination Product: Tissue Engineered Vascular Grafts Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery
Study Start Date : December 2009
Actual Primary Completion Date : December 26, 2017
Actual Study Completion Date : January 23, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Tissue Engineered Vascular Grafts Combination Product: Tissue Engineered Vascular Grafts
Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance angiography (MRA)


Outcome Measures
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Primary Outcome Measures :
  1. graft failure requiring intervention [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. graft growth [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • incomplete inferior vena cava (IVC)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034007


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Christopher Breuer
Doris Duke Charitable Foundation
Gunze Limited
Investigators
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Study Chair: Christopher K Breuer, MD Nationwide Children's Hospital, Columbus, Ohio
Study Chair: Toshiharu Shinoka, MD/PhD Nationwide Children's Hospital, Columbus, Ohio
Principal Investigator: Mark Galantowicz, MD Nationwide Children's Hospital
More Information
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Responsible Party: Christopher Breuer, Director of Tissue Engineering, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01034007    
Other Study ID Numbers: NCHIRB12-00357
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Keywords provided by Christopher Breuer, Nationwide Children's Hospital:
tissue engineered vascular graft
Additional relevant MeSH terms:
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Univentricular Heart
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities