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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT07191093
Eligibility Criteria:
Inclusion Criteria:
* Any age group(no age restriction) Diagnosis of isolated valvular pulmonary stenosis confirmed by echocardiographic evaluation.
Patients who have undergone or are scheduled to undergo successful pulmonary balloon valvuloplasty (PBV), defined as a post-procedural peak gradient \<40 mmHg with no significant residual obstruction.
Normal or mildly dysplastic pulmonary valve morphology suitable for balloon valvuloplasty.
No history of prior cardiac surgery or transcatheter pulmonary valve intervention.
Exclusion Criteria:
* Presence of other congenital heart diseases (e.g., TOF, VSD, ASD) Previous surgical or catheter-based intervention on the pulmonary valve. Dysplastic pulmonary valve morphology not suitable for PBV Subvalvular or supravalvular pulmonary stenosis. Development of significant procedural complications, such as severe pulmonary regurgitation requiring urgent surgical intervention.
Patients in hemodynamic shock, with uncontrolled arrhythmias, or other unstable clinical conditions that may interfere with echocardiographic evaluation or follow-up.
Presence of major systemic illnesses (e.g., advanced hepatic, renal, or pulmonary disease) that could independently affect right heart function or limit follow-up.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07191093
Study Brief:
Protocol Section:
NCT07191093