Clinical Characteristics and Associations of the "Good Fontan" Patient
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Children's Hospital
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Surprise question
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Surprise question
Time Frame: 1 year
The ability of the cardiologist's response to the "surprise" question to predict adverse cardiac events within 1 year
Secondary Outcomes
- Clinical characteristics and associations of the "good Fontan"(1 year)
- Correlation between patient and provider assessments(1 year)
- Clinician factors associated with adverse events conversation with patients(1 year)
Investigators
Rahul Rathod
Cardiologist
Boston Children's Hospital