Clinical Characteristics and Associations of the "Good Fontan" Patient

Boston Children's Hospital

Status: Completed

Conditions: Single-ventricle; Congenital Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT03470428

IRB-P00024716

Details and patient eligibility

About

This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse event in their Fontan patients.

Full description

This is a multi-center prospective study that involves collecting data from patients as well as their cardiology providers in order to determine whether there is correlation between patient-reported quality of life assessments and clinician-identified assessments of their patients. The study also involves collecting data from the medical records of participating patients and entering it into our study database.

Enrollment: 146 patients

Sex: All

Ages: 10 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Extracardiac or Lateral Funnel Fontan

Exclusion criteria

• Currently being evaluated for or listed for cardiac transplant
• Underwent Fontan revision or conversion
• Currently pregnant

Trial design

146 participants in 2 patient groups

Pediatric Fontan Patients

Description:

Participants ages 10 to 18 who have had Lateral Tunnel or Extracardiac Fontan procedures.

Adult Fontan Patients

Description:

Participants ages 18 to 60 who have had Lateral Tunnel or Extracardiac Fontan procedures.