Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01HL068270 | U.S. NIH Grant/Contract | View source | |
| U01HL068269 | U.S. NIH Grant/Contract | View source | |
| U01HL068279 | U.S. NIH Grant/Contract | View source | |
| U01HL068281 | U.S. NIH Grant/Contract | View source | |
| U01HL068285 | U.S. NIH Grant/Contract | View source | |
| U01HL068288 | U.S. NIH Grant/Contract | View source | |
| U01HL068290 | U.S. NIH Grant/Contract | View source | |
| U01HL068292 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Pediatric Heart Network | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
BACKGROUND:
Hypoplastic 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.
This study has been approved by the Institutional Review/Research Ethics Boards of all participating clinical centers:
Hospital for Sick Children, Toronto, Canada
Children's Hospital Boston, Boston, MA
Columbia College of Physicians and Surgeons, New York, NY
Children's Hospital of Philadelphia, Philadelphia, PA
Duke University Medical Center, Durham, NC
Brody School of Medicine at East Carolina University, Greenville, NC
Wake Forest Baptist Medical Center, Winston Salem, NC
Medical University of South Carolina, Charleston, SC
Children's Hospital of Wisconsin, Milwaukee, WI
University of Michigan, Ann Arbor, MI
Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Children's Hospital of Los Angeles, Los Angeles, CA
Egleston Children's Hospital, Emory University, Atlanta, GA
Congenital Heart Institute of Florida, University of South Florida, St. Petersburg, FL
Alfred I. duPont Hospital for Children, Wilmington, DE
DESIGN NARRATIVE:
This is a prospective, randomized clinical trial of the RV-to-PA shunt versus MBTS in patients undergoing a Norwood procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBTS | Active Comparator | Blalock-Taussig pulmonary artery shunt |
|
| RVPAS | Active Comparator | Right ventricular to pulmonary artery shunt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blalock-Taussig pulmonary artery shunt | Procedure | Performed at stage I palliative surgery for babies born with HLHS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Died or Received a Heart Transplant | The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization. | Measured at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial | This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial. | From Randomization to the End of the Trial, an average of 32 months |
| Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julie E Miller, MPH | New England Research Institutes, Watertown, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Alfred I. duPont Hospital for Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18954638 | Background | 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. | |
| 21331516 |
Not provided
Not provided
There were no pre-assignment requirements beyond the initial screening criteria.
Subjects undergoing a Norwood were randomized to MBTS or RVPAS at 15 North American centers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MBTS | Blalock-Taussig pulmonary artery shunt |
| FG001 | RVPAS | Right ventricular to pulmonary artery shunt |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Right ventricular to pulmonary artery shunt | Procedure | Performed at stage I palliative surgery for babies born with HLHS |
|
|
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. |
| Measured post-Norwood, an average of 17 days post-Norwood |
| Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA | 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. | Measured pre-stage II surgery, an average of 15 days pre-stage II surgery |
| Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA | 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. | Measured at 14 months of age |
| Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA | 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. | Measured post-Norwood, an average of 17 days post-Norwood |
| Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA | 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. | Measured pre-stage II surgery, an average of 15 days pre-stage II surgery |
| Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA | 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. | Measured at 14 months of age |
| Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction | 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. | Measured post-Norwood, an average of 17 days post-Norwood |
| Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction | 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. | Measured pre-stage II surgery, an average of 15 days pre-stage II surgery |
| Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction | 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. | Measured at 14 months of age |
| Angiographic Findings: Left Pulmonary Artery Size | Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II). | Measured pre-stage II surgery, on average 26 days prior to stage II palliation |
| Angiographic Findings: Right Pulmonary Artery Size | Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II). | Measured pre-stage II surgery, on average 26 days prior to stage II palliation |
| Unintended Cardiovascular Interventional Procedures | 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. | From Randomization to 12 months |
| Complications: Total Number Experienced During Norwood Hospitalization | 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. | Norwood Hospitalization, an average of 36 days |
| Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge | 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. | From Norwood Discharge to Stage II discharge, an average of 4.2 months |
| Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age | 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. | From Stage II Discharge to 14 Months of Age, an average of 8.9 months |
| Wilmington |
| Delaware |
| 19899 |
| United States |
| Cardiac Surgical Associates | St. Petersburg | Florida | 33709 | United States |
| Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | 30033 | United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health System/Mott Hospital | Ann Arbor | Michigan | 48109 | United States |
| Columbia College of Physicians and Surgeons | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Result |
| 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. |
| 21397260 | Result | 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. |
| 20561642 | Result | 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. |
| 20505177 | Result | 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. |
| 17308942 | Result | 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. Epub 2007 Feb 16. |
| 41811273 | Derived | Hill KD, Kang L, Wang Q, Newburger JW, Gaynor JW, Burns KM, Williams R, Trachtenberg F, McCrindle BW, Graham EM, Pizarro C, Ashfaq A, Souza A, Kuo JA, Ilardi D, Schumacher KR, Hong H, Goldberg CS; Pediatric Heart Network Investigators. Single-Ventricle Disease: Long-Term Outcomes and Global Morbidity in the Single Ventricle Reconstruction Trial. J Am Coll Cardiol. 2026 Jun 9;87(22):3114-3133. doi: 10.1016/j.jacc.2026.01.049. Epub 2026 Mar 11. |
| 41706109 | Derived | Cnota JF, Chowdhury SM, Floh A, Gongwer R, Goot BH, Jacobs JP, Jolley MA, Kirmani S, LaPar DJ, Levine JC, Lewis AB, Pignatelli RH, Pizarro C, Slesnick TC, Thorsson T, Trachtenberg F, Truong DT, Newburger JW, Frommelt PC; Pediatric Heart Network Investigators. Tricuspid Regurgitation and Impact of Surgical Valve Intervention in the Single Ventricle Reconstruction Trial. Pediatr Cardiol. 2026 Feb 18. doi: 10.1007/s00246-025-04122-x. Online ahead of print. |
| 37866470 | Derived | Mahle WT, Keesari R, Trachtenberg F, Newburger JW, Lim H, Edelson J, Jeewa A, Lal A, Kindel SJ, Burns KM, Lang S, Bainton J, Carboni M, Villa CR, Richmond M, Henderson H, Menteer J, Pizarro C, Goldberg CS. School age and adolescent heart failure following the Norwood procedure. J Heart Lung Transplant. 2024 Mar;43(3):453-460. doi: 10.1016/j.healun.2023.10.012. Epub 2023 Oct 20. |
| 36073629 | Derived | Dolgner SJ, Tjoeng YL, Chan T. Analysis of the Single Ventricle Reconstruction Trial Using Restricted Mean Survival Time and Shunt Type Received. J Am Heart Assoc. 2022 Sep 20;11(18):e025978. doi: 10.1161/JAHA.122.025978. Epub 2022 Sep 8. No abstract available. |
| 30979811 | Derived | Miller TA, Ghanayem NS, Newburger JW, McCrindle BW, Hu C, DeWitt AG, Cnota JF, Tractenberg FL, Pemberton VL, Wolf MJ, Votava-Smith JK, Fifer CG, Lambert LM, Shah A, Graham EM, Pizarro C, Jacobs JP, Miller SG, Minich LL; Pediatric Heart Network Investigators. Gestational Age, Birth Weight, and Outcomes Six Years After the Norwood Procedure. Pediatrics. 2019 May;143(5):e20182577. doi: 10.1542/peds.2018-2577. Epub 2019 Apr 12. |
| 30755054 | Derived | Frommelt PC, Hu C, Trachtenberg F, Baffa JM, Boruta RJ, Chowdhury S, Cnota JF, Dragulescu A, Levine JC, Lu J, Mercer-Rosa L, Miller TA, Shah A, Slesnick TC, Stapleton G, Stelter J, Wong P, Newburger JW. Impact of Initial Shunt Type on Echocardiographic Indices in Children After Single Right Ventricle Palliations. Circ Cardiovasc Imaging. 2019 Feb;12(2):e007865. doi: 10.1161/CIRCIMAGING.118.007865. |
| 29571602 | Derived | Mahle WT, Hu C, Trachtenberg F, Menteer J, Kindel SJ, Dipchand AI, Richmond ME, Daly KP, Henderson HT, Lin KY, McCulloch M, Lal AK, Schumacher KR, Jacobs JP, Atz AM, Villa CR, Burns KM, Newburger JW; Pediatric Heart Network Investigators. Heart failure after the Norwood procedure: An analysis of the Single Ventricle Reconstruction Trial. J Heart Lung Transplant. 2018 Jul;37(7):879-885. doi: 10.1016/j.healun.2018.02.009. Epub 2018 Feb 16. |
| 29437119 | Derived | Newburger JW, Sleeper LA, Gaynor JW, Hollenbeck-Pringle D, Frommelt PC, Li JS, Mahle WT, Williams IA, Atz AM, Burns KM, Chen S, Cnota J, Dunbar-Masterson C, Ghanayem NS, Goldberg CS, Jacobs JP, Lewis AB, Mital S, Pizarro C, Eckhauser A, Stark P, Ohye RG; Pediatric Heart Network Investigators. Transplant-Free Survival and Interventions at 6 Years in the SVR Trial. Circulation. 2018 May 22;137(21):2246-2253. doi: 10.1161/CIRCULATIONAHA.117.029375. Epub 2018 Feb 1. |
| 29420218 | Derived | Bucholz EM, Sleeper LA, Newburger JW. Neighborhood Socioeconomic Status and Outcomes Following the Norwood Procedure: An Analysis of the Pediatric Heart Network Single Ventricle Reconstruction Trial Public Data Set. J Am Heart Assoc. 2018 Feb 2;7(3):e007065. doi: 10.1161/JAHA.117.007065. |
| 28734628 | Derived | Ramroop R, Manase G, Lu D, Manase D, Chen S, Kim R, Lee T, Mahle WT, McHugh K, Mitchell M, Tristani-Firouzi M, Wechsler SB, Wilder NS, Zak V, Lafreniere-Roula M, Newburger JW, Gaynor JW, Russell MW, Mital S. Adrenergic receptor genotypes influence postoperative outcomes in infants in the Single-Ventricle Reconstruction Trial. J Thorac Cardiovasc Surg. 2017 Nov;154(5):1703-1710.e3. doi: 10.1016/j.jtcvs.2017.06.041. Epub 2017 Jun 24. |
| 28687711 | Derived | Meza JM, Hickey EJ, Blackstone EH, Jaquiss RDB, Anderson BR, Williams WG, Cai S, Van Arsdell GS, Karamlou T, McCrindle BW. The Optimal Timing of Stage 2 Palliation for Hypoplastic Left Heart Syndrome: An Analysis of the Pediatric Heart Network Single Ventricle Reconstruction Trial Public Data Set. Circulation. 2017 Oct 31;136(18):1737-1748. doi: 10.1161/CIRCULATIONAHA.117.028481. Epub 2017 Jul 7. |
| 28043455 | Derived | Chowdhury SM, Graham EM, Atz AM, Bradley SM, Kavarana MN, Butts RJ. Validation of a Simple Score to Determine Risk of Hospital Mortality After the Norwood Procedure. Semin Thorac Cardiovasc Surg. 2016 Summer;28(2):425-433. doi: 10.1053/j.semtcvs.2016.04.004. Epub 2016 Apr 19. |
| 27855999 | Derived | Burch PT, Ravishankar C, Newburger JW, Lambert LM, Pemberton VL, Granger S, Floh AA, Anderson JB, Hill GD, Hill KD, Oster ME, Lewis AB, Schumacher KR, Zyblewski SC, Davies RR, Jacobs JP, Lai WW, Minich LL; Pediatric Heart Network Investigators. Assessment of Growth 6 Years after the Norwood Procedure. J Pediatr. 2017 Jan;180:270-274.e6. doi: 10.1016/j.jpeds.2016.09.048. Epub 2016 Nov 14. |
| 27167022 | Derived | Plummer ST, Hornik CP, Baker H, Fleming GA, Foerster S, Ferguson ME, Glatz AC, Hirsch R, Jacobs JP, Lee KJ, Lewis AB, Li JS, Martin M, Porras D, Radtke WA, Rhodes JF, Vincent JA, Zampi JD, Hill KD. Maladaptive aortic properties after the Norwood procedure: An angiographic analysis of the Pediatric Heart Network Single Ventricle Reconstruction Trial. J Thorac Cardiovasc Surg. 2016 Aug;152(2):471-479.e3. doi: 10.1016/j.jtcvs.2016.03.091. Epub 2016 Apr 14. |
| 25599806 | Derived | Yilmaz B, Narayan HK, Wilpers A, Wiess C, Fifer WP, Williams IA. Electrocardiographic intervals in foetuses with CHD. Cardiol Young. 2016 Jan;26(1):84-9. doi: 10.1017/S1047951114002686. Epub 2015 Jan 20. |
| 25440099 | Derived | Frommelt PC, Gerstenberger E, Cnota JF, Cohen MS, Gorentz J, Hill KD, John JB, Levine JC, Lu J, Mahle WT, McCandless RT, Mertens L, Pearson GD, Spencer C, Thacker D, Williams IA, Wong PC, Newburger JW; Pediatric Heart Network Investigators. Impact of initial shunt type on cardiac size and function in children with single right ventricle anomalies before the Fontan procedure: the single ventricle reconstruction extension trial. J Am Coll Cardiol. 2014 Nov 11;64(19):2026-35. doi: 10.1016/j.jacc.2014.08.033. Epub 2014 Nov 3. |
| 24958780 | Derived | 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. |
| 24952712 | Derived | 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. |
| 24705119 | Derived | 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. |
| 24210923 | Derived | 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. |
| 24097422 | Derived | 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. |
| 24075564 | Derived | 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. |
| 23864006 | Derived | 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. |
| 23537971 | Derived | 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. |
| 22980631 | Derived | 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. |
| 22901498 | Derived | 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. |
| 22795436 | Derived | 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. |
| 22704284 | Derived | 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. |
| 22698562 | Derived | 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. |
| 22523314 | Derived | 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. |
| 22456475 | Derived | 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. |
| 22341427 | Derived | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MBTS | Blalock-Taussig pulmonary artery shunt |
| BG001 | RVPAS | Right ventricular to pulmonary artery shunt |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | days |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Who Died or Received a Heart Transplant | The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization. | 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. | Posted | Number | Participants | Measured at 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial | This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial. | Posted | Number | Participants | From Randomization to the End of the Trial, an average of 32 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA) | 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. | 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. | Posted | Median | Inter-Quartile Range | ml/m^2.6 | Measured post-Norwood, an average of 17 days post-Norwood |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA | 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. | 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. | Posted | Median | Inter-Quartile Range | ml/m^2.6 | Measured pre-stage II surgery, an average of 15 days pre-stage II surgery |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA | 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. | 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. | Posted | Median | Inter-Quartile Range | ml/m^2.6 | Measured at 14 months of age |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA | 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. | 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. | Posted | Median | Inter-Quartile Range | ml/m^2.6 | Measured post-Norwood, an average of 17 days post-Norwood |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA | 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. | 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. | Posted | Median | Inter-Quartile Range | ml/m^2.6 | Measured pre-stage II surgery, an average of 15 days pre-stage II surgery |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA | 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. | 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. | Posted | Median | Inter-Quartile Range | ml/m^2.6 | Measured at 14 months of age |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction | 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. | 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. | Posted | Mean | Standard Deviation | Percentage of RV end-diastolic volume | Measured post-Norwood, an average of 17 days post-Norwood |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction | 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. | 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. | Posted | Mean | Standard Deviation | Percentage of RV end-diastolic volume | Measured pre-stage II surgery, an average of 15 days pre-stage II surgery |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction | 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. | 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. | Posted | Mean | Standard Deviation | Percentage of RV end-diastolic volume | Measured at 14 months of age |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Angiographic Findings: Left Pulmonary Artery Size | Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II). | These patients had pre-stage II palliation visits with acceptable cardiac catheterizations. | Posted | Mean | Standard Deviation | mm | Measured pre-stage II surgery, on average 26 days prior to stage II palliation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Angiographic Findings: Right Pulmonary Artery Size | Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II). | These patients had pre-stage II palliation visits with acceptable cardiac catheterizations. | Posted | Mean | Standard Deviation | mm | Measured pre-stage II surgery, on average 26 days prior to stage II palliation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Unintended Cardiovascular Interventional Procedures | 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. | Posted | Number | procedures | From Randomization to 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complications: Total Number Experienced During Norwood Hospitalization | 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. | Posted | Number | complications | Norwood Hospitalization, an average of 36 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge | 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. | These numbers reflect those patients who were discharged from the hospital after the Norwood procedure and were transplant free. | Posted | Number | complications | From Norwood Discharge to Stage II discharge, an average of 4.2 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age | 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. | These numbers reflect the number of patients who were discharged from the hospital after the Stage 2 procedure and were transplant-free. | Posted | Number | complications | From Stage II Discharge to 14 Months of Age, an average of 8.9 months |
|
|
Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MBTS | Blalock-Taussig pulmonary artery shunt | 146 | 275 | 249 | 275 | ||
| EG001 | RVPAS | Right ventricular to pulmonary artery shunt | 112 | 274 | 251 | 274 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrhythmia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac general | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coagulation | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hemorrhage/bleeding | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Metabolic/laboratory | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal/soft tissue | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neurology | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal/genitourinary | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Surgery/intra-operative injury | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | PHN coding dictionar | Systematic Assessment |
| |
| Gastrointestinal | Gastrointestinal disorders | PHN coding dictionar | Systematic Assessment |
| |
| Hematologic | Blood and lymphatic system disorders | PHN coding dictionar | Systematic Assessment |
| |
| Infectious | Infections and infestations | PHN coding dictionar | Systematic Assessment |
| |
| Neurological | Nervous system disorders | PHN coding dictionar | Systematic Assessment |
| |
| Respiratory | Respiratory, thoracic and mediastinal disorders | PHN coding dictionar | Systematic Assessment |
| |
| Renal | Renal and urinary disorders | PHN coding dictionar | Systematic Assessment |
| |
| Vascular | Vascular disorders | PHN coding dictionar | Systematic Assessment |
|
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.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Sleeper, ScD | New England Research Institutes | 617-972-3235 | lsleeper@neriscience.com |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D058366 | Blalock-Taussig Procedure |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Canada |
|
| Superiority or Other (legacy) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|