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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07375602
Eligibility Criteria:
Inclusion Criteria:
* Age ≤ 18 years at the time of transcatheter procedure.
* Diagnosis of perimembranous ventricular septal defect confirmed by echocardiography, and underwent transcatheter device closure at the study center.
* Medical records sufficient to ascertain the primary outcome within the pre-specified follow-up window, and availability of minimum baseline clinical information required for model development/validation.
Exclusion Criteria:
* Ventricular septal defects not classified as perimembranous on echocardiography, including muscular, outlet, or inlet VSDs, as well as multiple or complex VSDs involving more than one septal region.
* Presence of complex congenital heart disease or associated structural abnormalities requiring concomitant surgical repair (e.g., tetralogy of Fallot).
* Prior surgical VSD repair or prior transcatheter VSD closure.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT07375602
Study Brief:
Protocol Section:
NCT07375602