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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT00557934
Eligibility Criteria:
Inclusion Criteria:
1. Corrected tetralogy of Fallot or other surgery with involvement of the pulmonary valve, chronic pulmonary regurgitation, dilated right ventricle
2. Patient's age \> 4 years
3. Routine cardiac catheterization clinically indicated for deciding therapeutic treatment
4. Informed assent/consent of patients/parent.
Exclusion Criteria:
1. Pregnancy/breast feeding, women of child-bearing age without contraception.
2. Present participation, and/or participation in a clinical study during the last 4 weeks.
3. Illnesses or malfunctions, which exclude a participation in this study after decision of the investigating physician.
4. Other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT00557934
Study Brief:
Protocol Section:
NCT00557934