Researchers Studying Safety and Performance of TEVGs in Fontan Population
Phase: Recruiting
Condition(s): Congenital Heart Disease
What Is the Purpose of This Study?
To look at the safety of using a new type of tissue engineered vascular graft (TEVG) to see if it might be better than artificial grafts for use in surgeries for heart problems. Researchers are also looking to confirm that these new grafts grow as your body grows.
Who Can Take Part in This Study?
Children with congenital heart disease who are undergoing Fontan surgery.
What Will Happen During This Study?
The study will last about 2 years. Major study procedures include:
- A bone marrow aspirate on the day of surgery to make the graft
- 4 MRIs over 2 years
- Taking a medicine called Losartan for 2 weeks
- Taking warfarin for 6 months along with aspirin
- Visits with your heart doctor (cardiologist) around months 1, 2, 6, 12, 18, and 24 after surgery
- A monthly telephone call
Will We Be Paid for This Study?
Yes, you will be compensated for your time.
Principal Investigator
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