Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Children's Hospital Los Angeles

Status: Enrolling

Conditions: Single-ventricle; Stenosis

Treatments: Diagnostic Test: Cardiopulmonary Exercise Testing (CPET); Diagnostic Test: Shear Wave Elastography Scan

Study type: Observational

Funder types: Other

Identifiers

NCT07073612

CHLA-25-00052

Details and patient eligibility

About

The goal of this observational study is to assess the clinical impact following Fontan stent placement for extracardiac Fontan conduit (EFC) stenosis in patients with single-ventricle Fontan-palliated patients ages 12-21 years old.

The main question it aims to:

-Assess changes in exercise capacity by cardiopulmonary exercise testing and liver stiffness assessed by shear wave elastography before and after EFC stenting.

Participants will undergo two cardiopulmonary exercise tests and three shear wave elastography scans.

Enrollment: 20 estimated patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Functionally single-ventricle Fontan-palliated patients undergoing clinically indicated cardiac catheterization
• Anticipated Fontan stent placement for extracardiac Fontan conduit stenosis at the discretion of the primary operator
• Weight ≥ 50 kg
• 12-21 years of age

Exclusion criteria

• Interrupted IVC
• Greater than mild atrioventricular valve regurgitation on most recent echocardiogram or MRI (RF > 20%).
• Greater than mild systemic ventricular dysfunction on most recent echo or MRI (EF < 40%).
• Non-sinus rhythm
• Pacemaker
• Inability to perform exercise test due to developmental or physical disability

Trial design

20 participants in 1 patient group

Cohort

Description:

Single ventricle fontan.

Treatment:

Diagnostic Test: Shear Wave Elastography Scan

Diagnostic Test: Cardiopulmonary Exercise Testing (CPET)