At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of hypoplastic left heart syndrome or related single, morphologic right ventricle anomaly
- ✓Planned Norwood procedure
- ✓Informed consent of parent(s) or legal guardian
- ✕Single, morphologic left ventricle anomaly
- ✕Preoperative identification of anatomy rendering either an MBTS or an RV-to-PA shunt technically impossible
- ✕Major congenital abnormality (e.g., congenital diaphragmatic hernia, tracheoesophageal fistula) or acquired extra-cardiac disorder (e.g., meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis) that could independently affect the likelihood of meeting the primary endpoint
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Trial of Right Ventricular Versus Modified Blalock-Taussig Shunt in Infants With Single Ventricle Defect Undergoing Staged Reconstruction (A Trial Conducted by the Pediatric Heart Network)
In Brief
A clinical study evaluating Blalock-Taussig pulmonary artery shunt and Right ventricular to pulmonary artery shunt for Heart Defects, Congenital. Completed, enrolled 555 participants across 13 sites in 2 countries.
Detailed Summary
This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS) compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of the MBTS to that of the RV-to-PA shunt on the incidence of death or cardiac transplantation at 12 months post randomization; and compare the effect of the two shunts on intensive care unit (ICU) morbidity, unintended cardiovascular interventional procedures, right ventricular function, tricuspid valve regurgitation, pulmonary artery growth, and neurodevelopmental outcome.
Study Details
Timeline
Interventions
Performed at stage I palliative surgery for babies born with HLHS
Performed at stage I palliative surgery for babies born with HLHS