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: February 26, 2014
Last verified: February 2014

January 29, 2008
February 26, 2014
December 2009
December 2018   (final data collection date for primary outcome measure)
graft failure requiring intervention [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01034007 on ClinicalTrials.gov Archive Site
graft growth [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery
A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Single Ventricle Cardiac Anomaly
Device: Tissue Engineered Vascular Grafts
Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance angiography (MRA)
Experimental: Tissue Engineered Vascular Grafts
Intervention: Device: Tissue Engineered Vascular Grafts
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
6
December 2018
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • incomplete inferior vena cava (IVC)
Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01034007
NCHIRB12-00357
Yes
Christopher Breuer, Nationwide Children's Hospital
Christopher Breuer
  • Doris Duke Charitable Foundation
  • Gunze Limited
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
Nationwide Children's Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP