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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Doris Duke Charitable Foundation
Gunze Limited
Information provided by (Responsible Party):
Christopher Breuer, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01034007
First received: January 29, 2008
Last updated: May 6, 2015
Last verified: May 2015
  Purpose

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 Intervention Phase
Single Ventricle Cardiac Anomaly
Device: Tissue Engineered Vascular Grafts
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • graft failure requiring intervention [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • graft growth [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: December 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tissue Engineered Vascular Grafts Device: Tissue Engineered Vascular Grafts
Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance angiography (MRA)

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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034007

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Christopher Breuer
Doris Duke Charitable Foundation
Gunze Limited
Investigators
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

No publications provided

Responsible Party: Christopher Breuer, Director of Tissue Engineering, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01034007     History of Changes
Other Study ID Numbers: NCHIRB12-00357
Study First Received: January 29, 2008
Last Updated: May 6, 2015
Health Authority: United States: Food and Drug Administration
United States: Data Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
tissue engineered vascular graft

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases

ClinicalTrials.gov processed this record on August 26, 2015