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

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) |
- graft failure requiring intervention [ Time Frame: 3 years ]
- graft growth [ Time Frame: 3 years ]

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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 |
Inclusion Criteria:
- single ventricle cardiac anomaly requiring extra cardiac total cavopulmonary connection (EC TCPC).
Exclusion Criteria:
- incomplete inferior vena cava (IVC)

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
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 |
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 |
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 |
tissue engineered vascular graft |
Univentricular Heart Heart Defects, Congenital Cardiovascular Abnormalities |
Cardiovascular Diseases Heart Diseases Congenital Abnormalities |