Status:
NOT_YET_RECRUITING
Venous Compression in Fontan
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Single-ventricle
Fontan Circulation
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The aim of this study is to investigate whether venous compression garments increase exercise stroke volume in patients with Fontan circulation. To address this aim, we will test the following hypothe...
Detailed Description
Study Day 1 - Consent, Screening and Garment Measurements: Following assessment of participant eligibility, all participants will undergo leg venous ultrasound assessment and abdominal-foot measureme...
Eligibility Criteria
Inclusion
- Patients with a Fontan circulation -
- Inclusion criteria:
- • Patients at UTSW aged 18-45 years old with a Fontan circulation.
- Exclusion Criteria:
- NYHA Class 4
- Severe AV valve regurgitation
- Severe ventricular dysfunction
- Large ascites
- Significant varicosities
- Atrio-pulmonary (AP) Fontan
- Known Fontan thrombus
- Poorly controlled arrythmia
- Unplanned cardiac admission in the last 6 months
- Cyanosis (resting O2 saturation \<85%)
- Pregnant
- Common femoral vein obstruction \>50% to be performed following completion of informed consent.
- Healthy Controls:
- Healthy control participants will be recruited on the basis of having no known chronic diseases and not currently taking any cardiovascular medications.
Exclusion
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07220226
Start Date
December 1 2025
End Date
November 1 2027
Last Update
October 23 2025
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