Clinical Characteristics and Associations of the "Good Fontan" Patient
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03470428|
Recruitment Status : Active, not recruiting
First Posted : March 20, 2018
Last Update Posted : July 28, 2021
|Condition or disease|
|Congenital Heart Disease Single-ventricle|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Clinical Characteristics and Associations of the "Good Fontan" Patient|
|Actual Study Start Date :||March 5, 2018|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2026|
Pediatric Fontan Patients
Participants ages 10 to 18 who have had Lateral Tunnel or Extracardiac Fontan procedures.
Adult Fontan Patients
Participants ages 18 to 60 who have had Lateral Tunnel or Extracardiac Fontan procedures.
- 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
- Clinical characteristics and associations of the "good Fontan" [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470428
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Rahul Rathod, MD||Boston Children's Hospital|