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:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT00112320
Eligibility Criteria:
Inclusion Criteria:
* Undergoing PVR to repair TOF at Children's Hospital Boston
* Pulmonary regurgitation fraction greater than or equal to 25% (measured by CMR) and two or more of the following criteria:
1. RV end-diastolic volume index greater than or equal to 150 ml/m2 (Z score greater than 5)
2. RV end-systolic volume index greater than or equal to 70 ml/m2
3. LV end-diastolic volume index less than or equal to 65 ml/m2
4. RV ejection fraction less than 45%
5. RVOT aneurysm
6. Clinical criteria: exercise intolerance, symptoms and signs of heart failure, and use of cardiac medications
Exclusion Criteria:
* Presence of either severe RV outflow tract obstruction (defined as peak-to-peak systolic gradient of greater than or equal to 60 mm Hg by cardiac catheterization) or severe RV hypertension at systemic or higher level
* Additional sources of RV volume overload other than PR and tricuspid valve regurgitation
* Contraindications to CMR
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT00112320
Study Brief:
Protocol Section:
NCT00112320