Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT02919956
Eligibility Criteria:
Inclusion Criteria:
SV Patients
* Subjects ages 3 to 15 years old who have completed their Fontan procedure and their parents/guardians.
* Any complex congenital heart lesion that has SV physiology of either right ventricle (RV) or left ventricle (LV) morphology.
* Ability to undergo a 60-90 minute MRI scan under general anesthesia or deep sedation if general anesthesia or sedation is needed.
* Parents signing informed consent. Healthy Controls
* Males and females ages 3 to 15 years old if in the original cohort and if not in the original cohort, age matched with Groups I and II, and their parents/guardians.
* Normal cerebral and cardiac anatomy who are normocephalic and who are asymptomatic.
* For normal controls being prospectively enrolled and not part of the original grant, the ability to extend the clinical MRI an extra 15-20 minutes.
* For normal controls undergoing sedation, the ability to extend anesthesia for approximately 15-30 minutes for research purposes only.
* Parents signing informed consent. Volunteers
* Patients who come to CHOP for a clinically indicated MRI.
* The ability to extend the clinical MRI an extra 15-20 minutes.
* If 18 or over, patient signing informed consent.
* If under 18, parents signing informed consent.
Exclusion Criteria:
SV Patients
* A patient whose primary language is not English. Patients who speak English who have parents or guardians who do not speak English would not be excluded.
* Any condition judged by the patient's physician that would cause this trial to be detrimental to the patient.
* Any known significant neurological disease outside of the usual state of SV patients.
* Any major anomalies which would confound neurological outcome.
* A patient with a pacemaker or cardioverter/defibrillator in place.
* A contraindicated ferromagnetic foreign body).
* Pregnancy Healthy Controls
* An individual whose primary language is not English. Patients who speak English who have parents or guardians who do not speak English would not be excluded
* Any condition judged by the patient's physician that would cause this trial to be detrimental to the patient.
* Any known significant neurological disease.
* Any contraindication to extending the MRI.
* Pregnancy. Volunteers
* A patient whose primary language is not English. Patients who speak English who have parents or guardians who do not speak English would not be excluded.
* Any condition judged by the patient's physician that would cause this trial to be detrimental to the patient.
* Any contraindication to extending the MRI.
* Pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT02919956
Study Brief:
Protocol Section:
NCT02919956