Status:
ACTIVE_NOT_RECRUITING
Predictors of RV Dysfunction After BPV
Lead Sponsor:
Assiut University
Conditions:
RV Dysfunction
Pulmonary Valvuloplasty
Eligibility:
All Genders
Brief Summary
This aim focuses on : Assessing how common RV dysfunction is post-procedure Evaluating RV function changes over time (e.g., TAPSE, FAC, RV strain if available) Identifying risk factors or predictors ...
Detailed Description
Pulmonary stenosis (PS) is a congenital or acquired narrowing of the right ventricular outflow tract (RVOT) at the level of the pulmonary valve, leading to obstruction of blood flow from the right ven...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07191093
Start Date
August 1 2025
End Date
October 1 2026
Last Update
September 24 2025
Active Locations (1)
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1
Assiut University
Asyut, Egypt