Clinical Characteristics and Associations of the Good Fontan Patient

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Characteristics and Associations of the Good Fontan Patient

Conditions
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Congenital Heart Disease, Single-ventricle

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Fontan Patients<br>Participants ages 10 to 18 who have had Lateral Tunnel or Extracardiac Fontan procedures. | |
| Adult Fontan Patients<br>Participants ages 18 to 60 who have had Lateral Tunnel or Extracardiac Fontan procedures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surprise question | The ability of the cardiologist's response to the surprise question to predict adverse cardiac events within 1 year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical characteristics and associations of the good Fontan | 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. | 1 year | 
| Correlation between patient and provider assessments | 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. | 1 year | 
| Clinician factors associated with adverse events conversation with patients | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fontan, Single Ventricle