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Send to a FriendSingle Ventricle Reconstruction Trial
Principal Investigator: Richard G. Ohye, MD, University of Michigan Medical School, Ann Arbor, Michigan USA
The Norwood procedure for patients born with hypoplastic left heart syndrome (HLHS) and related single right ventricle anomalies remains one of the highest-risk procedures in congenital heart surgery. The classic Norwood procedure provides blood flow to the lungs using a modified Blalock-Taussig shunt (MBTS). Improved outcomes have been reported in a few small, non-randomized studies in which a right ventricle-to-pulmonary artery (RV-to-PA) shunt is used to provide pulmonary blood flow following the Norwood procedure. Other non-randomized studies comparing the two techniques have shown no difference in hospital mortality.
The Pediatric Heart Network (PHN) is a collaboration of eight congenital heart centers funded by the National Heart, Lung, Blood Institute of the National Institutes of Health to conduct clinical trials in congenital heart disease. One of the PHN trials is the Single Ventricle Reconstruction (SVR) trial, a randomized clinical trial to compare outcomes for subjects undergoing a Norwood procedure with either the RV-to-PA or MBTS. The SVR trial involves all of the primary SVR centers, as well as 8 additional ancillary sites. Infants, who are undergoing a Norwood procedure and have single, morphologically right ventricle anatomy, are eligible for inclusion in this study. The primary outcomes studied are death or cardiac transplantation 12 months after randomization. Secondary outcomes studied include postoperative morbidity following the Norwood and stage II palliation procedures, RV function and pulmonary artery growth at stage II palliation, and neurodevelopmental outcomes at 14 months of age. The incidence of adverse events will also be compared between the treatment groups.
The SVR trial is anticipated to enroll a total of 554 patients with an estimated close-out date in late spring 2008. This study will make an important contribution to the management of patients with HLHS and related forms of single, morphologically right ventricle. As the first randomized, multi-center trial to compare two surgical techniques in congenital heart surgery, it also establishes a model by which other operative interventions for patients with congenital cardiovascular malformations can be evaluated in the future.