An observational study in Cyanotic Congenital Heart Disease and Right Ventricular Outflow Tract Obstruction, sponsored by Assiut University. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Assiut University · Observational
This prospective observational cohort study aims to compare clinical and hemodynamic outcomes of percutaneous right ventricular outflow tract stenting versus surgical right ventricle-to-pulmonary artery conduit placement in cyanotic adults with congenital heart disease.
Cyanotic congenital heart disease in adults often involves significant right ventricular outflow tract obstruction. Establishing adequate pulmonary blood flow can be achieved by percutaneous right ventricular outflow tract (RVOT) stenting or surgical right ventricle-to-pulmonary artery (RV-PA) conduit placement.
This observational study will compare changes in systemic oxygen saturation, echocardiographic parameters, and clinical outcomes between the two treatment approaches in adult patients aged 16 years or older.
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's planned enrollment of 30 is below the median of 121 across 442 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients aged 16 years or older with cyanotic congenital heart disease and significant right ventricular outflow tract obstruction undergoing either percutaneous RVOT stenting or surgical RV-PA conduit placement at Aswan Heart Center.
Exclusion Criteria:
Adult patients undergoing percutaneous right ventricular outflow tract stent implantation.
Adult patients undergoing surgical right ventricle-to-pulmonary artery conduit placement.
Change in systemic oxygen saturation
Mean change in resting systemic oxygen saturation (SpO2) in percentage from baseline to 12 months.
Time frame: At 12 months
Change in peak RVOT gradient
Mean change in peak right ventricular outflow tract gradient in mmHg measured by echocardiography.
Time frame: At 12 months
Change in TAPSE
Mean change in tricuspid annular plane systolic excursion (TAPSE) in millimeters measured by echocardiography.
Time frame: At 12 months
Number of patients with improvement in NYHA class
Number of patients showing improvement of at least one New York Heart Association functional class.
Time frame: At 12 months
Length of hospital stay
Mean length of hospital stay in days after the index procedure.
Time frame: At 1 month
Number of patients requiring reintervention
Number of patients who undergo unplanned reintervention during follow-up.
Time frame: At 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Assiut University