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 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT05647161
Eligibility Criteria:
Inclusion Criteria:
1. Patients \<12 years of age
2. Patients who have undergone the first scheduled palliative surgery for the following diseases and are scheduled to undergo re-do open heart surgery (anatomical repair surgery):
* Ventricular septal defect
* Atrioventricular septal defect
* Tetralogy of Fallot (spectrum)
* Single ventricle disease (The participant should not meet the exclusion criteria (1) to (3)).
3. Patients who will undergo BT shunting or pulmonary artery banding (including bilateral pulmonary artery banding) for the first surgery
4. Patients undergoing repair surgery (anatomical repair surgery) or bi-directional Glenn surgery as the second target procedure
5. Patients for whom written consent has been obtained from the patient or a surrogate
Exclusion Criteria:
1. Patients with hypoplastic left heart syndrome (HLHS) and its analogues.
2. Patients with asplenia or hypersplenism.
3. Patients undergoing Norwood surgery as the second surgery.
4. Patients undergoing open heart surgery prior to the first scheduled palliative surgery.
5. Patients with complications of other organs that affect the indication for cardiac surgery.
6. Patients with chromosomal or genetic abnormalities that may affect the indication for cardiac surgery.
7. Patients with severe infections or multiple organ failure.
8. Patients who require emergency surgery that requires emergency life support.
9. Patients' body weight is less than 2,500g at birth.
10. Patients who are participating in other clinical trials or who are scheduled to participate in other clinical trials during this study period.
11. Patients who are judged by the investigator or sub investigator to be inappropriate to participate in this study for other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
12 Years
Study:
NCT05647161
Study Brief:
Protocol Section:
NCT05647161