Status:
COMPLETED
The Effect of Fontan Fenestration Closure on Hepatic Stiffness
Lead Sponsor:
Boston Children's Hospital
Conditions:
Single-ventricle
Hepatic Congestion
Eligibility:
All Genders
Brief Summary
The overarching goal of this project is to discern how closure of Fontan fenestrations in patients with single ventricle heart disease will affect hepatic congestion, a major determinant of chronic li...
Detailed Description
Methods Eligible patients will be contacted in advance of hospitalization for catheterized fenestration closure to introduce goals of study and review risks and benefits of participation. At the time ...
Eligibility Criteria
Inclusion
- Functional Single ventricle patients after a fenestrated lateral tunnel or extra-cardiac Fontan
- Patients scheduled for possible fenestration closure in the catheterization laboratory
- Informed consent has been obtained
Exclusion
- Patients with spontaneous closure of Fenestration
- Ascites
- Ventilatory requirement
- Implantable cardiac device
- Ongoing inotropic support
- Pregnancy
- Inability to tolerate four hour pre-procedure fasting
Key Trial Info
Start Date :
May 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03481985
Start Date
May 29 2018
End Date
June 30 2022
Last Update
April 19 2023
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115