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Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network

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ClinicalTrials.gov Identifier: NCT00115934
Recruitment Status : Completed
First Posted : June 27, 2005
Results First Posted : June 27, 2011
Last Update Posted : April 20, 2016
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network
Information provided by (Responsible Party):
New England Research Institutes

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Defects, Congenital
Interventions Procedure: Blalock-Taussig pulmonary artery shunt
Procedure: Right ventricular to pulmonary artery shunt
Enrollment 555

Recruitment Details Subjects undergoing a Norwood were randomized to MBTS or RVPAS at 15 North American centers.
Pre-assignment Details There were no pre-assignment requirements beyond the initial screening criteria.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description Blalock-Taussig pulmonary artery shunt Right ventricular to pulmonary artery shunt
Period Title: Overall Study
Started 279 [1] 276 [2]
Completed 275 274
Not Completed 4 2
Reason Not Completed
Lost to Follow-up             1             0
Did not receive intervention             3             2
[1]
279 randomized to MBTS, but 3 did not have a Norwood surgery; one was withdrawn-with limited data.
[2]
276 randomized to RVPAS, but 2 did not have a Norwood surgery and were excluded from analyses.
Arm/Group Title MBTS RVPAS Total
Hide Arm/Group Description Blalock-Taussig pulmonary artery shunt Right ventricular to pulmonary artery shunt Total of all reporting groups
Overall Number of Baseline Participants 275 274 549
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 274 participants 549 participants
<=18 years
275
 100.0%
274
 100.0%
549
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 275 participants 274 participants 549 participants
5.1  (4.1) 5.0  (4.0) 5.1  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 274 participants 549 participants
Female
107
  38.9%
102
  37.2%
209
  38.1%
Male
168
  61.1%
172
  62.8%
340
  61.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 275 participants 274 participants 549 participants
United States 268 266 534
Canada 7 8 15
1.Primary Outcome
Title Proportion of Patients Who Died or Received a Heart Transplant
Hide Description The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.
Time Frame Measured at 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 275 274
Measure Type: Number
Unit of Measure: Participants
100 72
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -10.1
Confidence Interval 95%
-17.8 to -2.4
Estimation Comments 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.
2.Secondary Outcome
Title Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial
Hide Description This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.
Time Frame From Randomization to the End of the Trial, an average of 32 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 275 274
Measure Type: Number
Unit of Measure: Participants
107 88
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)
Hide 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.
Time Frame Measured post-Norwood, an average of 17 days post-Norwood
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 173 194
Median (Inter-Quartile Range)
Unit of Measure: ml/m^2.6
91.2
(76.3 to 108.1)
86.5
(73.8 to 104.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA
Hide 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.
Time Frame Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 127 151
Median (Inter-Quartile Range)
Unit of Measure: ml/m^2.6
113.4
(94.1 to 138.6)
105.2
(86.8 to 125.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA
Hide 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.
Time Frame Measured at 14 months of age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 107 129
Median (Inter-Quartile Range)
Unit of Measure: ml/m^2.6
83.3
(69.4 to 100.3)
88.9
(72.6 to 104.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Hide 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.
Time Frame Measured post-Norwood, an average of 17 days post-Norwood
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 173 194
Median (Inter-Quartile Range)
Unit of Measure: ml/m^2.6
50.1
(40.2 to 61.9)
44.2
(36.6 to 57.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Hide 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.
Time Frame Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 127 151
Median (Inter-Quartile Range)
Unit of Measure: ml/m^2.6
63.2
(49.9 to 83.0)
57.9
(44.6 to 69.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments Wilcoxon rank-sum test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA
Hide 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.
Time Frame Measured at 14 months of age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 107 129
Median (Inter-Quartile Range)
Unit of Measure: ml/m^2.6
45.4
(38.5 to 56.6)
50.5
(39.7 to 60.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Hide 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.
Time Frame Measured post-Norwood, an average of 17 days post-Norwood
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 173 194
Mean (Standard Deviation)
Unit of Measure: Percentage of RV end-diastolic volume
44.5  (7.6) 48.5  (7.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Hide 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.
Time Frame Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 128 151
Mean (Standard Deviation)
Unit of Measure: Percentage of RV end-diastolic volume
42.9  (7.9) 44.7  (8.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction
Hide 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.
Time Frame Measured at 14 months of age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 107 129
Mean (Standard Deviation)
Unit of Measure: Percentage of RV end-diastolic volume
42.7  (7.4) 42.7  (8.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Angiographic Findings: Left Pulmonary Artery Size
Hide Description Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).
Time Frame Measured pre-stage II surgery, on average 26 days prior to stage II palliation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 159 191
Mean (Standard Deviation)
Unit of Measure: mm
5.2  (1.5) 5.4  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Angiographic Findings: Right Pulmonary Artery Size
Hide Description Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).
Time Frame Measured pre-stage II surgery, on average 26 days prior to stage II palliation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 159 191
Mean (Standard Deviation)
Unit of Measure: mm
6.1  (2.0) 5.4  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title Unintended Cardiovascular Interventional Procedures
Hide 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.
Time Frame From Randomization to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 275 274
Measure Type: Number
Unit of Measure: procedures
192 252
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Poisson regression
Comments The offset parameter used in the poisson regression was the log of the number of patients in each treatment arm.
15.Secondary Outcome
Title Complications: Total Number Experienced During Norwood Hospitalization
Hide 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.
Time Frame Norwood Hospitalization, an average of 36 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 275 274
Measure Type: Number
Unit of Measure: complications
850 792
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Poisson Regression
Comments The offset parameter used in this analysis was the log of the number of patients per treatment arm.
16.Secondary Outcome
Title Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge
Hide 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.
Time Frame From Norwood Discharge to Stage II discharge, an average of 4.2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These numbers reflect those patients who were discharged from the hospital after the Norwood procedure and were transplant free.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 219 233
Measure Type: Number
Unit of Measure: complications
367 515
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Poisson Regression
Comments The offset parameter used in this analysis was the log of the number of patients per treatment arm.
17.Secondary Outcome
Title Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age
Hide 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.
Time Frame From Stage II Discharge to 14 Months of Age, an average of 8.9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These numbers reflect the number of patients who were discharged from the hospital after the Stage 2 procedure and were transplant-free.
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description:
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt
Overall Number of Participants Analyzed 176 202
Measure Type: Number
Unit of Measure: complications
81 145
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MBTS, RVPAS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Poisson regression
Comments The offset parameter used in this analysis was the log of the number of patients per treatment arm.
Time Frame Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented.
Adverse Event Reporting 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.
 
Arm/Group Title MBTS RVPAS
Hide Arm/Group Description Blalock-Taussig pulmonary artery shunt Right ventricular to pulmonary artery shunt
All-Cause Mortality
MBTS RVPAS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MBTS RVPAS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   146/275 (53.09%)      112/274 (40.88%)    
Blood and lymphatic system disorders     
Coagulation  1  1/275 (0.36%)  1 1/274 (0.36%)  1
Hemorrhage/bleeding  1  4/275 (1.45%)  4 6/274 (2.19%)  6
Cardiac disorders     
Cardiac arrhythmia  1  7/275 (2.55%)  8 9/274 (3.28%)  10
Cardiac general  1  97/275 (35.27%)  111 63/274 (22.99%)  73
Gastrointestinal disorders     
Gastrointestinal  1  3/275 (1.09%)  3 3/274 (1.09%)  3
Infections and infestations     
Infection  1  7/275 (2.55%)  7 9/274 (3.28%)  9
Metabolism and nutrition disorders     
Metabolic/laboratory  1  1/275 (0.36%)  1 2/274 (0.73%)  2
Musculoskeletal and connective tissue disorders     
Musculoskeletal/soft tissue  1  1/275 (0.36%)  1 0/274 (0.00%)  0
Nervous system disorders     
Neurology  1  5/275 (1.82%)  6 4/274 (1.46%)  4
Renal and urinary disorders     
Renal/genitourinary  1  3/275 (1.09%)  3 3/274 (1.09%)  3
Respiratory, thoracic and mediastinal disorders     
Pulmonary/upper respiratory  1  11/275 (4.00%)  11 11/274 (4.01%)  11
Surgical and medical procedures     
Surgery/intra-operative injury  1  4/275 (1.45%)  4 4/274 (1.46%)  4
Vascular disorders     
Vascular  1  35/275 (12.73%)  36 29/274 (10.58%)  29
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MBTS RVPAS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   249/275 (90.55%)      251/274 (91.61%)    
Blood and lymphatic system disorders     
Hematologic  1  48/275 (17.45%)  64 57/274 (20.80%)  73
Cardiac disorders     
Cardiac disorders  1  161/275 (58.55%)  316 148/274 (54.01%)  266
Gastrointestinal disorders     
Gastrointestinal  1  93/275 (33.82%)  138 94/274 (34.31%)  133
Infections and infestations     
Infectious  1  156/275 (56.73%)  313 172/274 (62.77%)  401
Nervous system disorders     
Neurological  1  35/275 (12.73%)  51 53/274 (19.34%)  77
Renal and urinary disorders     
Renal  1  39/275 (14.18%)  41 27/274 (9.85%)  28
Respiratory, thoracic and mediastinal disorders     
Respiratory  1  154/275 (56.00%)  285 172/274 (62.77%)  387
Vascular disorders     
Vascular  1  32/275 (11.64%)  34 34/274 (12.41%)  38
Indicates events were collected by systematic assessment
1
Term from vocabulary, PHN coding dictionar
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lynn Sleeper, ScD
Organization: New England Research Institutes
Phone: 617-972-3235
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00115934     History of Changes
Other Study ID Numbers: 194
U01HL068270 ( U.S. NIH Grant/Contract )
U01HL068269 ( U.S. NIH Grant/Contract )
U01HL068279 ( U.S. NIH Grant/Contract )
U01HL068281 ( U.S. NIH Grant/Contract )
U01HL068285 ( U.S. NIH Grant/Contract )
U01HL068288 ( U.S. NIH Grant/Contract )
U01HL068290 ( U.S. NIH Grant/Contract )
U01HL068292 ( U.S. NIH Grant/Contract )
First Submitted: June 26, 2005
First Posted: June 27, 2005
Results First Submitted: September 14, 2010
Results First Posted: June 27, 2011
Last Update Posted: April 20, 2016