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Clinical Trials in Egypt / NCT07191093
Active, not recruiting Observational

Predictors of RV Dysfunction After BPV

NCT07191093 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Observational
Started
2025-08-01
Last updated
2025-09-24

Condition(s) studied

RV DysfunctionPulmonary Valvuloplasty

Investigational drug(s) / intervention(s)

pulmonary valvuloplasty

pulmonary valvuloplasty: Pulmonary balloon valvuloplasty (PBV) is the treatment of choice for moderate to severe valvular pulmonary stenosis. It is a minimally invasive, catheter-based intervention that involves dilation of the stenotic pulmonary valve using an appropriately sized balloon. The goal is to relieve obstruction, reduce right ventricular pressure, and prevent long-term complications such as RV hypertrophy, dysfunction, and arrhythmias. The procedure has shown excellent immediate and long-term outcomes, particularly in patients with a pliable, doming pulmonary valve and no significant regurgitation or associated congenital lesions.

Study 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 (e.g., high residual gradient, severe PR, age at intervention)

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in peak transvalvular gradient after PBV — Baseline, 72 hours post-procedure, and 6 months follow-up.
  • Change in mean transvalvular gradient after pulmonary balloon valvuloplasty — Baseline, 72 hours post-procedure, and 6 months follow-up.
  • Change in estimated pulmonary artery systolic pressure PASP after PBV — Baseline, 72 hours post-procedure, and 6 months follow-up.
  • Change in TAPSE after PBV — Baseline, 72 hours post-procedure, and 12 months follow-up

Trial sites (1)

FacilityCityRegionStatus
Assiut University Asyut Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07191093 on ClinicalTrials.gov ↗ ← All trials in Egypt