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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:
Yale University
ClinicalTrials.gov Identifier:
NCT01034007
First received: January 29, 2008
Last updated: June 25, 2010
Last verified: June 2010
History of Changes
  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
 Procedure: EC TCPC interposition grafting
 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:

U.S. FDA Resources

Further study details as provided by Yale University:

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 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tissue Engineered Vascular Grafts Procedure: EC TCPC interposition grafting
Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance angiography (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034007

Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Doris Duke Charitable Foundation
Gunze Limited
Investigators
Principal Investigator: Chris Breuer, MD Yale University
  More Information

No publications provided

Responsible Party: Chris Breuer & Toshi Shinoka, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT01034007     History of Changes
Other Study ID Numbers: 07701002198
Study First Received: January 29, 2008
Last Updated: June 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
tissue engineered vascular graft

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

ClinicalTrials.gov processed this record on May 22, 2013