Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-02-06 @ 12:44 AM
Study NCT ID:
NCT00115934
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2005-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058366', 'term': 'Blalock-Taussig Procedure'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lsleeper@neriscience.com', 'phone': '617-972-3235', 'title': 'Lynn Sleeper, ScD', 'organization': 'New England Research Institutes'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'As in all surgical trials comparing two operations, it was not possible to blind the personnel caring for the subjects to the intervention. However, the components of the primary endpoint, death and transplantation, are discrete objective events.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented.', 'description': 'Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt', 'otherNumAtRisk': 275, 'otherNumAffected': 249, 'seriousNumAtRisk': 275, 'seriousNumAffected': 146}, {'id': 'EG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt', 'otherNumAtRisk': 274, 'otherNumAffected': 251, 'seriousNumAtRisk': 274, 'seriousNumAffected': 112}], 'otherEvents': [{'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 316, 'numAffected': 161}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 266, 'numAffected': 148}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'PHN coding dictionar'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 138, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 133, 'numAffected': 94}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'PHN coding dictionar'}, {'term': 'Hematologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 64, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 73, 'numAffected': 57}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'PHN coding dictionar'}, {'term': 'Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 313, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 401, 'numAffected': 172}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'PHN coding dictionar'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 51, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 77, 'numAffected': 53}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'PHN coding dictionar'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 285, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 387, 'numAffected': 172}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'PHN coding dictionar'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 41, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 28, 'numAffected': 27}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'PHN coding dictionar'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 38, 'numAffected': 34}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'PHN coding dictionar'}], 'seriousEvents': [{'term': 'Cardiac arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac general', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 111, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 73, 'numAffected': 63}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hemorrhage/bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Metabolic/laboratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Musculoskeletal/soft tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neurology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pulmonary/upper respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Renal/genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Surgery/intra-operative injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 36, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Who Died or Received a Heart Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-10.1', 'ciLowerLimit': '-17.8', 'ciUpperLimit': '-2.4', 'estimateComment': 'The risk difference is defined as the percent of subjects with events in the RVPAS group minus the percent of subjects with events in the MBTS group.', 'groupDescription': 'The original sample size of 456 was based on 85% power, with a two-sided, two sample test of proportions (anticipating 28% MBTS subjects with events, 16% RVPAS subjects with events), and an alpha of 0.05. The critical p-value was 0.044 because four interim analyses were performed. The target trial size was increased from 466 to 554 to account for crossovers. The stopping boundary was crossed at the 4th interim look; however, the trial was not halted, because all subjects were enrolled.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at 12 months', 'description': 'The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '555 subjects were enrolled in the study; 5 of these subjects were excluded from analyses because a Norwood procedure was not performed; 1 subject was excluded because the subject withdrew before the 12-month follow-up, 12-month status was unknown. The data were analyzed on an intention to treat basis, subjects were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Randomization to the End of the Trial, an average of 32 months', 'description': 'This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000', 'lowerLimit': '76.3', 'upperLimit': '108.1'}, {'value': '86.5', 'groupId': 'OG001', 'lowerLimit': '73.8', 'upperLimit': '104.3'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured post-Norwood, an average of 17 days post-Norwood', 'description': 'Right ventricular end-diastolic volume indexed to BSA\\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.', 'unitOfMeasure': 'ml/m^2.6', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or measures were not able to be obtained to calculate the volumes.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '113.4', 'groupId': 'OG000', 'lowerLimit': '94.1', 'upperLimit': '138.6'}, {'value': '105.2', 'groupId': 'OG001', 'lowerLimit': '86.8', 'upperLimit': '125.3'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured pre-stage II surgery, an average of 15 days pre-stage II surgery', 'description': 'Right ventricular end-diastolic volume indexed to BSA\\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.', 'unitOfMeasure': 'ml/m^2.6', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '69.4', 'upperLimit': '100.3'}, {'value': '88.9', 'groupId': 'OG001', 'lowerLimit': '72.6', 'upperLimit': '104.7'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured at 14 months of age', 'description': 'Right ventricular end-diastolic volume indexed to BSA\\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.', 'unitOfMeasure': 'ml/m^2.6', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '61.9'}, {'value': '44.2', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '57.1'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured post-Norwood, an average of 17 days post-Norwood', 'description': 'Right ventricular end-systolic volume indexed to BSA. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.', 'unitOfMeasure': 'ml/m^2.6', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000', 'lowerLimit': '49.9', 'upperLimit': '83.0'}, {'value': '57.9', 'groupId': 'OG001', 'lowerLimit': '44.6', 'upperLimit': '69.9'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Wilcoxon rank-sum test', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured pre-stage II surgery, an average of 15 days pre-stage II surgery', 'description': 'Right ventricular end-systolic volume indexed to BSA\\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.', 'unitOfMeasure': 'ml/m^2.6', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000', 'lowerLimit': '38.5', 'upperLimit': '56.6'}, {'value': '50.5', 'groupId': 'OG001', 'lowerLimit': '39.7', 'upperLimit': '60.8'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured at 14 months of age', 'description': 'Right ventricular end-systolic volume indexed to BSA\\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.', 'unitOfMeasure': 'ml/m^2.6', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '48.5', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured post-Norwood, an average of 17 days post-Norwood', 'description': 'Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.', 'unitOfMeasure': 'Percentage of RV end-diastolic volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes used to calculate the ejection fraction.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '44.7', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured pre-stage II surgery, an average of 15 days pre-stage II surgery', 'description': 'Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.', 'unitOfMeasure': 'Percentage of RV end-diastolic volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.'}, {'type': 'SECONDARY', 'title': 'Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '42.7', 'spread': '8.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 14 months of age', 'description': 'Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.', 'unitOfMeasure': 'Percentage of RV end-diastolic volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.'}, {'type': 'SECONDARY', 'title': 'Angiographic Findings: Left Pulmonary Artery Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured pre-stage II surgery, on average 26 days prior to stage II palliation', 'description': 'Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.'}, {'type': 'SECONDARY', 'title': 'Angiographic Findings: Right Pulmonary Artery Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured pre-stage II surgery, on average 26 days prior to stage II palliation', 'description': 'Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.'}, {'type': 'SECONDARY', 'title': 'Unintended Cardiovascular Interventional Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The offset parameter used in the poisson regression was the log of the number of patients in each treatment arm.'}], 'paramType': 'NUMBER', 'timeFrame': 'From Randomization to 12 months', 'description': 'Unintended cardiovascular procedures included balloon dilation of the shunt or branch pulmonary arteries, stent placement in the shunt or branch pulmonary arteries, shunt revision, crossover between MBTS and RVPAS shunt, balloon dilation, stent placement or surgical revisions of the neo-aorta, and pulmonary artery reconstructions, other than those undertaken as a standard component of the stage II procedure. The number of cardiovascular procedures was analyzed; trial participants may have had more than one unintended cardiovascular. procedure.', 'unitOfMeasure': 'procedures', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications: Total Number Experienced During Norwood Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '850', 'groupId': 'OG000'}, {'value': '792', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Poisson Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The offset parameter used in this analysis was the log of the number of patients per treatment arm.'}], 'paramType': 'NUMBER', 'timeFrame': 'Norwood Hospitalization, an average of 36 days', 'description': "Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.", 'unitOfMeasure': 'complications', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '367', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Poisson Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The offset parameter used in this analysis was the log of the number of patients per treatment arm.'}], 'paramType': 'NUMBER', 'timeFrame': 'From Norwood Discharge to Stage II discharge, an average of 4.2 months', 'description': "Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.", 'unitOfMeasure': 'complications', 'reportingStatus': 'POSTED', 'populationDescription': 'These numbers reflect those patients who were discharged from the hospital after the Norwood procedure and were transplant free.'}, {'type': 'SECONDARY', 'title': 'Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'OG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The offset parameter used in this analysis was the log of the number of patients per treatment arm.'}], 'paramType': 'NUMBER', 'timeFrame': 'From Stage II Discharge to 14 Months of Age, an average of 8.9 months', 'description': "Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.", 'unitOfMeasure': 'complications', 'reportingStatus': 'POSTED', 'populationDescription': 'These numbers reflect the number of patients who were discharged from the hospital after the Stage 2 procedure and were transplant-free.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'FG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '279 randomized to MBTS, but 3 did not have a Norwood surgery; one was withdrawn-with limited data.', 'groupId': 'FG000', 'numSubjects': '279'}, {'comment': '276 randomized to RVPAS, but 2 did not have a Norwood surgery and were excluded from analyses.', 'groupId': 'FG001', 'numSubjects': '276'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not receive intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects undergoing a Norwood were randomized to MBTS or RVPAS at 15 North American centers.', 'preAssignmentDetails': 'There were no pre-assignment requirements beyond the initial screening criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '549', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt'}, {'id': 'BG001', 'title': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '549', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '5.0', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '340', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '534', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 555}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2005-06-26', 'resultsFirstSubmitDate': '2010-09-14', 'studyFirstSubmitQcDate': '2005-06-26', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-05-27', 'studyFirstPostDateStruct': {'date': '2005-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Who Died or Received a Heart Transplant', 'timeFrame': 'Measured at 12 months', 'description': 'The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial', 'timeFrame': 'From Randomization to the End of the Trial, an average of 32 months', 'description': 'This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.'}, {'measure': 'Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)', 'timeFrame': 'Measured post-Norwood, an average of 17 days post-Norwood', 'description': 'Right ventricular end-diastolic volume indexed to BSA\\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.'}, {'measure': 'Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA', 'timeFrame': 'Measured pre-stage II surgery, an average of 15 days pre-stage II surgery', 'description': 'Right ventricular end-diastolic volume indexed to BSA\\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.'}, {'measure': 'Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA', 'timeFrame': 'Measured at 14 months of age', 'description': 'Right ventricular end-diastolic volume indexed to BSA\\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.'}, {'measure': 'Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA', 'timeFrame': 'Measured post-Norwood, an average of 17 days post-Norwood', 'description': 'Right ventricular end-systolic volume indexed to BSA. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.'}, {'measure': 'Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA', 'timeFrame': 'Measured pre-stage II surgery, an average of 15 days pre-stage II surgery', 'description': 'Right ventricular end-systolic volume indexed to BSA\\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.'}, {'measure': 'Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA', 'timeFrame': 'Measured at 14 months of age', 'description': 'Right ventricular end-systolic volume indexed to BSA\\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.'}, {'measure': 'Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction', 'timeFrame': 'Measured post-Norwood, an average of 17 days post-Norwood', 'description': 'Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.'}, {'measure': 'Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction', 'timeFrame': 'Measured pre-stage II surgery, an average of 15 days pre-stage II surgery', 'description': 'Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.'}, {'measure': 'Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction', 'timeFrame': 'Measured at 14 months of age', 'description': 'Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.'}, {'measure': 'Angiographic Findings: Left Pulmonary Artery Size', 'timeFrame': 'Measured pre-stage II surgery, on average 26 days prior to stage II palliation', 'description': 'Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).'}, {'measure': 'Angiographic Findings: Right Pulmonary Artery Size', 'timeFrame': 'Measured pre-stage II surgery, on average 26 days prior to stage II palliation', 'description': 'Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).'}, {'measure': 'Unintended Cardiovascular Interventional Procedures', 'timeFrame': 'From Randomization to 12 months', 'description': 'Unintended cardiovascular procedures included balloon dilation of the shunt or branch pulmonary arteries, stent placement in the shunt or branch pulmonary arteries, shunt revision, crossover between MBTS and RVPAS shunt, balloon dilation, stent placement or surgical revisions of the neo-aorta, and pulmonary artery reconstructions, other than those undertaken as a standard component of the stage II procedure. The number of cardiovascular procedures was analyzed; trial participants may have had more than one unintended cardiovascular. procedure.'}, {'measure': 'Complications: Total Number Experienced During Norwood Hospitalization', 'timeFrame': 'Norwood Hospitalization, an average of 36 days', 'description': "Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious."}, {'measure': 'Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge', 'timeFrame': 'From Norwood Discharge to Stage II discharge, an average of 4.2 months', 'description': "Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious."}, {'measure': 'Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age', 'timeFrame': 'From Stage II Discharge to 14 Months of Age, an average of 8.9 months', 'description': "Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Defects, Congenital']}, 'referencesModule': {'references': [{'pmid': '18954638', 'type': 'BACKGROUND', 'citation': 'Ohye RG, Gaynor JW, Ghanayem NS, Goldberg CS, Laussen PC, Frommelt PC, Newburger JW, Pearson GD, Tabbutt S, Wernovsky G, Wruck LM, Atz AM, Colan SD, Jaggers J, McCrindle BW, Prakash A, Puchalski MD, Sleeper LA, Stylianou MP, Mahony L; Pediatric Heart Network Investigators. Design and rationale of a randomized trial comparing the Blalock-Taussig and right ventricle-pulmonary artery shunts in the Norwood procedure. J Thorac Cardiovasc Surg. 2008 Oct;136(4):968-75. doi: 10.1016/j.jtcvs.2008.01.013. Epub 2008 May 19.'}, {'pmid': '21331516', 'type': 'RESULT', 'citation': 'Johnson JN, Ansong AK, Li JS, Xu M, Gorentz J, Hehir DA, del Castillo SL, Lai WW, Uzark K, Pasquali SK. Celiac artery flow pattern in infants with single right ventricle following the Norwood procedure with a modified Blalock-Taussig or right ventricle to pulmonary artery shunt. Pediatr Cardiol. 2011 Apr;32(4):479-86. doi: 10.1007/s00246-011-9906-y. Epub 2011 Feb 18.'}, {'pmid': '21397260', 'type': 'RESULT', 'citation': 'Virzi L, Pemberton V, Ohye RG, Tabbutt S, Lu M, Atz TC, Barnard T, Dunbar-Masterson C, Ghanayem NS, Jacobs JP, Lambert LM, Lewis A, Pike N, Pizarro C, Radojewski E, Teitel D, Xu M, Pearson GD. Reporting adverse events in a surgical trial for complex congenital heart disease: the Pediatric Heart Network experience. J Thorac Cardiovasc Surg. 2011 Sep;142(3):531-7. doi: 10.1016/j.jtcvs.2010.11.052. Epub 2011 Mar 12.'}, {'pmid': '20561642', 'type': 'RESULT', 'citation': 'Atz AM, Travison TG, Williams IA, Pearson GD, Laussen PC, Mahle WT, Cook AL, Kirsh JA, Sklansky M, Khaikin S, Goldberg C, Frommelt M, Krawczeski C, Puchalski MD, Jacobs JP, Baffa JM, Rychik J, Ohye RG; Pediatric Heart Network Investigators. Prenatal diagnosis and risk factors for preoperative death in neonates with single right ventricle and systemic outflow obstruction: screening data from the Pediatric Heart Network Single Ventricle Reconstruction Trial( *). J Thorac Cardiovasc Surg. 2010 Dec;140(6):1245-50. doi: 10.1016/j.jtcvs.2010.05.022. Epub 2010 Jun 18.'}, {'pmid': '20505177', 'type': 'RESULT', 'citation': 'Ohye RG, Sleeper LA, Mahony L, Newburger JW, Pearson GD, Lu M, Goldberg CS, Tabbutt S, Frommelt PC, Ghanayem NS, Laussen PC, Rhodes JF, Lewis AB, Mital S, Ravishankar C, Williams IA, Dunbar-Masterson C, Atz AM, Colan S, Minich LL, Pizarro C, Kanter KR, Jaggers J, Jacobs JP, Krawczeski CD, Pike N, McCrindle BW, Virzi L, Gaynor JW; Pediatric Heart Network Investigators. Comparison of shunt types in the Norwood procedure for single-ventricle lesions. N Engl J Med. 2010 May 27;362(21):1980-92. doi: 10.1056/NEJMoa0912461.'}, {'pmid': '17308942', 'type': 'RESULT', 'citation': 'Ohye RG, Devaney EJ, Hirsch JC, Bove EL. The modified Blalock-Taussig shunt versus the right ventricle-to-pulmonary artery conduit for the Norwood procedure. Pediatr Cardiol. 2007 Mar-Apr;28(2):122-5. doi: 10.1007/s00246-006-1449-2. 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Epub 2014 Nov 3.'}, {'pmid': '24958780', 'type': 'DERIVED', 'citation': 'Burch PT, Gerstenberger E, Ravishankar C, Hehir DA, Davies RR, Colan SD, Sleeper LA, Newburger JW, Clabby ML, Williams IA, Li JS, Uzark K, Cooper DS, Lambert LM, Pemberton VL, Pike NA, Anderson JB, Dunbar-Masterson C, Khaikin S, Zyblewski SC, Minich LL; Pediatric Heart Network Investigators. Longitudinal assessment of growth in hypoplastic left heart syndrome: results from the single ventricle reconstruction trial. J Am Heart Assoc. 2014 Jun 23;3(3):e000079. doi: 10.1161/JAHA.114.000079.'}, {'pmid': '24952712', 'type': 'DERIVED', 'citation': 'Goldberg CS, Lu M, Sleeper LA, Mahle WT, Gaynor JW, Williams IA, Mussatto KA, Ohye RG, Graham EM, Frank DU, Jacobs JP, Krawczeski C, Lambert L, Lewis A, Pemberton VL, Sananes R, Sood E, Wechsler SB, Bellinger DC, Newburger JW; Pediatric Heart Network Investigators. Factors associated with neurodevelopment for children with single ventricle lesions. J Pediatr. 2014 Sep;165(3):490-496.e8. doi: 10.1016/j.jpeds.2014.05.019. Epub 2014 Jun 19.'}, {'pmid': '24705119', 'type': 'DERIVED', 'citation': 'Newburger JW, Sleeper LA, Frommelt PC, Pearson GD, Mahle WT, Chen S, Dunbar-Masterson C, Mital S, Williams IA, Ghanayem NS, Goldberg CS, Jacobs JP, Krawczeski CD, Lewis AB, Pasquali SK, Pizarro C, Gruber PJ, Atz AM, Khaikin S, Gaynor JW, Ohye RG; Pediatric Heart Network Investigators. Transplantation-free survival and interventions at 3 years in the single ventricle reconstruction trial. Circulation. 2014 May 20;129(20):2013-20. doi: 10.1161/CIRCULATIONAHA.113.006191. Epub 2014 Apr 4.'}, {'pmid': '24210923', 'type': 'DERIVED', 'citation': 'Lambert LM, Pike NA, Medoff-Cooper B, Zak V, Pemberton VL, Young-Borkowski L, Clabby ML, Nelson KN, Ohye RG, Trainor B, Uzark K, Rudd N, Bannister L, Korsin R, Cooper DS, Pizarro C, Zyblewski SC, Bartle BH, Williams RV; Pediatric Heart Network Investigators. Variation in feeding practices following the Norwood procedure. J Pediatr. 2014 Feb;164(2):237-42.e1. doi: 10.1016/j.jpeds.2013.09.042. Epub 2013 Nov 6.'}, {'pmid': '24097422', 'type': 'DERIVED', 'citation': 'Marx GR, Shirali G, Levine JC, Guey LT, Cnota JF, Baffa JM, Border WL, Colan S, Ensing G, Friedberg MK, Goldberg DJ, Idriss SF, John JB, Lai WW, Lu M, Menon SC, Ohye RG, Saudek D, Wong PC, Pearson GD; Pediatric Heart Network Investigators. Multicenter study comparing shunt type in the norwood procedure for single-ventricle lesions: three-dimensional echocardiographic analysis. Circ Cardiovasc Imaging. 2013 Nov;6(6):934-42. doi: 10.1161/CIRCIMAGING.113.000304. Epub 2013 Oct 4.'}, {'pmid': '24075564', 'type': 'DERIVED', 'citation': 'Schwartz SM, Lu M, Ohye RG, Hill KD, Atz AM, Naim MY, Williams IA, Goldberg CS, Lewis A, Pigula F, Manning P, Pizarro C, Chai P, McCandless R, Dunbar-Masterson C, Kaltman JR, Kanter K, Sleeper LA, Schonbeck JV, Ghanayem N; Pediatric Heart Network Investigators. Risk factors for prolonged length of stay after the stage 2 procedure in the single-ventricle reconstruction trial. J Thorac Cardiovasc Surg. 2014 Jun;147(6):1791-8, 1798.e1-4. doi: 10.1016/j.jtcvs.2013.07.063. Epub 2013 Sep 24.'}, {'pmid': '23864006', 'type': 'DERIVED', 'citation': 'Hill KD, Rhodes JF, Aiyagari R, Baker GH, Bergersen L, Chai PJ, Fleming GA, Fudge JC, Gillespie MJ, Gray RG, Hirsch R, Lee KJ, Li JS, Ohye RG, Oster ME, Pasquali SK, Pelech AN, Radtke WA, Takao CM, Vincent JA, Hornik CP. Intervention for recoarctation in the single ventricle reconstruction trial: incidence, risk, and outcomes. Circulation. 2013 Aug 27;128(9):954-61. doi: 10.1161/CIRCULATIONAHA.112.000488. Epub 2013 Jul 17.'}, {'pmid': '23537971', 'type': 'DERIVED', 'citation': 'Williams IA, Fifer C, Jaeggi E, Levine JC, Michelfelder EC, Szwast AL. The association of fetal cerebrovascular resistance with early neurodevelopment in single ventricle congenital heart disease. Am Heart J. 2013 Apr;165(4):544-550.e1. doi: 10.1016/j.ahj.2012.11.013. Epub 2013 Feb 13.'}, {'pmid': '22980631', 'type': 'DERIVED', 'citation': 'Bacha E, del Nido P. Introduction to the Single Ventricle Reconstruction trial. J Thorac Cardiovasc Surg. 2012 Oct;144(4):880-1. doi: 10.1016/j.jtcvs.2012.08.031. No abstract available.'}, {'pmid': '22901498', 'type': 'DERIVED', 'citation': 'Ohye RG, Schonbeck JV, Eghtesady P, Laussen PC, Pizarro C, Shrader P, Frank DU, Graham EM, Hill KD, Jacobs JP, Kanter KR, Kirsh JA, Lambert LM, Lewis AB, Ravishankar C, Tweddell JS, Williams IA, Pearson GD; Pediatric Heart Network Investigators. Cause, timing, and location of death in the Single Ventricle Reconstruction trial. J Thorac Cardiovasc Surg. 2012 Oct;144(4):907-14. doi: 10.1016/j.jtcvs.2012.04.028. Epub 2012 Aug 15.'}, {'pmid': '22795436', 'type': 'DERIVED', 'citation': 'Ghanayem NS, Allen KR, Tabbutt S, Atz AM, Clabby ML, Cooper DS, Eghtesady P, Frommelt PC, Gruber PJ, Hill KD, Kaltman JR, Laussen PC, Lewis AB, Lurito KJ, Minich LL, Ohye RG, Schonbeck JV, Schwartz SM, Singh RK, Goldberg CS; Pediatric Heart Network Investigators. Interstage mortality after the Norwood procedure: Results of the multicenter Single Ventricle Reconstruction trial. J Thorac Cardiovasc Surg. 2012 Oct;144(4):896-906. doi: 10.1016/j.jtcvs.2012.05.020. Epub 2012 Jul 11.'}, {'pmid': '22704284', 'type': 'DERIVED', 'citation': 'Tabbutt S, Ghanayem N, Ravishankar C, Sleeper LA, Cooper DS, Frank DU, Lu M, Pizarro C, Frommelt P, Goldberg CS, Graham EM, Krawczeski CD, Lai WW, Lewis A, Kirsh JA, Mahony L, Ohye RG, Simsic J, Lodge AJ, Spurrier E, Stylianou M, Laussen P; Pediatric Heart Network Investigators. Risk factors for hospital morbidity and mortality after the Norwood procedure: A report from the Pediatric Heart Network Single Ventricle Reconstruction trial. J Thorac Cardiovasc Surg. 2012 Oct;144(4):882-95. doi: 10.1016/j.jtcvs.2012.05.019. Epub 2012 Jun 15.'}, {'pmid': '22698562', 'type': 'DERIVED', 'citation': 'Pasquali SK, Ohye RG, Lu M, Kaltman J, Caldarone CA, Pizarro C, Dunbar-Masterson C, Gaynor JW, Jacobs JP, Kaza AK, Newburger J, Rhodes JF, Scheurer M, Silver E, Sleeper LA, Tabbutt S, Tweddell J, Uzark K, Wells W, Mahle WT, Pearson GD; Pediatric Heart Network Investigators. Variation in perioperative care across centers for infants undergoing the Norwood procedure. J Thorac Cardiovasc Surg. 2012 Oct;144(4):915-21. doi: 10.1016/j.jtcvs.2012.05.021. Epub 2012 Jun 12.'}, {'pmid': '22523314', 'type': 'DERIVED', 'citation': 'Frommelt PC, Guey LT, Minich LL, Bhat M, Bradley TJ, Colan SD, Ensing G, Gorentz J, Heydarian H, John JB, Lai WW, Levine JC, Mahle WT, Miller SG, Ohye RG, Pearson GD, Shirali GS, Wong PC, Cohen MS; Pediatric Heart Network Investigators. Does initial shunt type for the Norwood procedure affect echocardiographic measures of cardiac size and function during infancy?: the Single Vventricle Reconstruction trial. Circulation. 2012 May 29;125(21):2630-8. doi: 10.1161/CIRCULATIONAHA.111.072694. Epub 2012 Apr 21.'}, {'pmid': '22456475', 'type': 'DERIVED', 'citation': 'Newburger JW, Sleeper LA, Bellinger DC, Goldberg CS, Tabbutt S, Lu M, Mussatto KA, Williams IA, Gustafson KE, Mital S, Pike N, Sood E, Mahle WT, Cooper DS, Dunbar-Masterson C, Krawczeski CD, Lewis A, Menon SC, Pemberton VL, Ravishankar C, Atz TW, Ohye RG, Gaynor JW; Pediatric Heart Network Investigators. Early developmental outcome in children with hypoplastic left heart syndrome and related anomalies: the single ventricle reconstruction trial. Circulation. 2012 May 1;125(17):2081-91. doi: 10.1161/CIRCULATIONAHA.111.064113. Epub 2012 Mar 28.'}, {'pmid': '22341427', 'type': 'DERIVED', 'citation': 'Tweddell JS, Sleeper LA, Ohye RG, Williams IA, Mahony L, Pizarro C, Pemberton VL, Frommelt PC, Bradley SM, Cnota JF, Hirsch J, Kirshbom PM, Li JS, Pike N, Puchalski M, Ravishankar C, Jacobs JP, Laussen PC, McCrindle BW; Pediatric Heart Network Investigators. Intermediate-term mortality and cardiac transplantation in infants with single-ventricle lesions: risk factors and their interaction with shunt type. J Thorac Cardiovasc Surg. 2012 Jul;144(1):152-9. doi: 10.1016/j.jtcvs.2012.01.016. Epub 2012 Feb 15.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "BACKGROUND:\n\nHypoplastic left heart syndrome (HLHS) and related single right ventricle anomalies are the highest risk congenital cardiovascular malformations. Surgical repair begins with the Norwood procedure during the newborn period, a stage II procedure at 4 to 6 months of age, and Fontan procedure at 18 to 36 months. The Norwood procedure remains one of the highest risk procedures in congenital heart surgery. A few small nonrandomized studies of a novel approach to the Norwood procedure have reported improved outcomes. This new approach uses a RV-to-PA shunt to provide pulmonary blood flow rather than the standard MBTS. This multi-center, randomized clinical trial will evaluate early and intermediate-term outcomes for patients undergoing a Norwood procedure with either the RV-to-PA shunt or the MBTS.\n\nThis study has been approved by the Institutional Review/Research Ethics Boards of all participating clinical centers:\n\nHospital for Sick Children, Toronto, Canada\n\nChildren's Hospital Boston, Boston, MA\n\nColumbia College of Physicians and Surgeons, New York, NY\n\nChildren's Hospital of Philadelphia, Philadelphia, PA\n\nDuke University Medical Center, Durham, NC\n\nBrody School of Medicine at East Carolina University, Greenville, NC\n\nWake Forest Baptist Medical Center, Winston Salem, NC\n\nMedical University of South Carolina, Charleston, SC\n\nChildren's Hospital of Wisconsin, Milwaukee, WI\n\nUniversity of Michigan, Ann Arbor, MI\n\nCincinnati Children's Hospital Medical Center, Cincinnati, OH\n\nChildren's Hospital of Los Angeles, Los Angeles, CA\n\nEgleston Children's Hospital, Emory University, Atlanta, GA\n\nCongenital Heart Institute of Florida, University of South Florida, St. Petersburg, FL\n\nAlfred I. duPont Hospital for Children, Wilmington, DE\n\nDESIGN NARRATIVE:\n\nThis is a prospective, randomized clinical trial of the RV-to-PA shunt versus MBTS in patients undergoing a Norwood procedure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of hypoplastic left heart syndrome or related single, morphologic right ventricle anomaly\n* Planned Norwood procedure\n* Informed consent of parent(s) or legal guardian\n\nExclusion Criteria:\n\n* Single, morphologic left ventricle anomaly\n* Preoperative identification of anatomy rendering either an MBTS or an RV-to-PA shunt technically impossible\n* Any major congenital abnormality (i.e., 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, in the opinion of the investigator, could independently affect the likelihood of the subject meeting the primary endpoint'}, 'identificationModule': {'nctId': 'NCT00115934', 'briefTitle': 'Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network', 'organization': {'class': 'OTHER', 'fullName': 'Carelon Research'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '194'}, 'secondaryIdInfos': [{'id': 'U01HL068270', 'link': 'https://reporter.nih.gov/quickSearch/U01HL068270', 'type': 'NIH'}, {'id': 'U01HL068269', 'link': 'https://reporter.nih.gov/quickSearch/U01HL068269', 'type': 'NIH'}, {'id': 'U01HL068279', 'link': 'https://reporter.nih.gov/quickSearch/U01HL068279', 'type': 'NIH'}, {'id': 'U01HL068281', 'link': 'https://reporter.nih.gov/quickSearch/U01HL068281', 'type': 'NIH'}, {'id': 'U01HL068285', 'link': 'https://reporter.nih.gov/quickSearch/U01HL068285', 'type': 'NIH'}, {'id': 'U01HL068288', 'link': 'https://reporter.nih.gov/quickSearch/U01HL068288', 'type': 'NIH'}, {'id': 'U01HL068290', 'link': 'https://reporter.nih.gov/quickSearch/U01HL068290', 'type': 'NIH'}, {'id': 'U01HL068292', 'link': 'https://reporter.nih.gov/quickSearch/U01HL068292', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MBTS', 'description': 'Blalock-Taussig pulmonary artery shunt', 'interventionNames': ['Procedure: Blalock-Taussig pulmonary artery shunt']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RVPAS', 'description': 'Right ventricular to pulmonary artery shunt', 'interventionNames': ['Procedure: Right ventricular to pulmonary artery shunt']}], 'interventions': [{'name': 'Blalock-Taussig pulmonary artery shunt', 'type': 'PROCEDURE', 'otherNames': ['MBTS procedure'], 'description': 'Performed at stage I palliative surgery for babies born with HLHS', 'armGroupLabels': ['MBTS']}, {'name': 'Right ventricular to pulmonary artery shunt', 'type': 'PROCEDURE', 'otherNames': ['RV to PA or Sano procedure'], 'description': 'Performed at stage I palliative surgery for babies born with HLHS', 'armGroupLabels': ['RVPAS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiac Surgical Associates', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30033', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta at Egleston", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System/Mott Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia College of Physicians and Surgeons', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Julie E Miller, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New England Research Institutes, Watertown, MA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carelon Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Pediatric Heart Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}