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 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT02791061
Eligibility Criteria:
Inclusion Criteria:
1. Survivors of TOF repair more than one year after repair without pulmonary stenosis (Doppler gradient more than 30mmHg) OR
2. Patients with moderate or severe pulmonary stenosis (Echo Doppler gradient more than 30mmHg)
3. Patients without prior Pulmonary Valve Replacement (PVR)
4. Written informed Consent obtained
5. Aged 13 to 80 years old
Exclusion Criteria:
1. Age less than 13
2. Contraindication to MRI Examination
* Cardiac Pacemaker
* Brain Aneurysm OR clips
* Electronic implants OR prosthesis
* Eye metal foreign body injury
* Severe claustrophobia
* Known severe impairment, glomerular filtration rate GFR less than 30 ml/min/BSA
3. Non Cardiac illness with life expectancy of less than 2 years
4. Previous heart kidney liver or lung transplantation Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
80 Years
Study:
NCT02791061
Study Brief:
Protocol Section:
NCT02791061