This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypoplastic left heart syndrome (HLHS) and related single right ventricle (RV) anomalies are the highest-risk congenital cardiovascular malformations (CCVM). Surgical palliation for these patients consists of the Norwood procedure during the newborn period, a stage II procedure at 4-6 months and the modified Fontan procedure at approximately 18 to 36 months. The Norwood procedure remains one of the highest risk procedures in congenital heart surgery. Recently, improved outcomes have been reported in a few small, non-randomized studies of a novel approach to the Norwood procedure, which uses a right ventricle to pulmonary artery (RV-to-PA) shunt to provide pulmonary blood flow rather than the standard modified Blalock-Taussig shunt (MBTS). The Pediatric Heart Network's proposed multi-institutional, randomized clinical trial will evaluate early and intermediate-term outcomes for patients undergoing a Norwood procedure with either the RV-to-PA shunt or MBTS. Infants with a diagnosis of single, morphologic right ventricle anomaly will be eligible for inclusion in this study. Participants will be randomly assigned to receive either a MBTS or RV-to-PA shunt, with randomization stratified by aortic atresia (presence or absence) and obstructed pulmonary venous return (presence or absence). Dynamic allocation will be used to ensure treatment arms are balanced across surgeons. Data will be collected at discharge from the Norwood procedure, prior to the stage II procedure (at approximately 6 months of age), and then again at 12 and 14 months post-randomization. The primary aim of the study will be to compare the effect of the MBTS to that of the RV-to-PA shunt on the rate of death or cardiac transplantation 12 months after randomization. Secondary aims include post-operative morbidity following the Norwood and stage II palliation procedures, RV function and pulmonary artery growth at the time of the stage II palliation, and neurodevelopmental outcome at 14 months. The incidence of adverse events will also be compared between the treatment groups. The total sample size target of 466 participants will be recruited over 26 months.
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