Congenital Heart Disease, Single-ventricle
Conditions
Keywords
Fontan, Single Ventricle
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.
Interventions
None listed
Sponsors
New England Congenital Cardiology Association (NECCA)
Yale University
Dartmouth College
Connecticut Children's Medical Center
University of Vermont
Child Heart Associates
Congenital Heart
University of Massachusetts, Worcester
Massachusetts General Hospital
Boston Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surprise question | 1 year | The ability of the cardiologist's response to the surprise question to predict adverse cardiac events within 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical characteristics and associations of the good Fontan | 1 year | Clinical characteristics and associations of this group (the good Fontan) are different compared to those that are in the at-risk category (all others that do not fit into the good Fontan category). Data measurements will include relevant clinical data available for each patient, including but not limited to data from cardiac surgeries, catheterizations, MRIs, echocardiograms, exercise stress tests, current medications, labs, and patient responses to questionnaires. |
| Correlation between patient and provider assessments | 1 year | There will be a positive correlation of the patient's own assessment of quality of life with the clinician-identified designation of a good Fontan. |
| Clinician factors associated with adverse events conversation with patients | 1 year | Clinician factors (years of experience, primary subspecialty, gender, parenthood) are associated with beliefs in regard to appropriate timing to discuss potential long-term adverse events to Fontan patients. |
Countries
United States
Outcome results
None listed