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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00115934
First Posted: June 27, 2005
Last Update Posted: April 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network
Information provided by (Responsible Party):
New England Research Institutes
Results First Submitted: September 14, 2010  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects undergoing a Norwood were randomized to MBTS or RVPAS at 15 North American centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no pre-assignment requirements beyond the initial screening criteria.

Reporting Groups
  Description
MBTS Blalock-Taussig pulmonary artery shunt
RVPAS Right ventricular to pulmonary artery shunt

Participant Flow:   Overall Study
    MBTS   RVPAS
STARTED   279 [1]   276 [2] 
COMPLETED   275   274 
NOT COMPLETED   4   2 
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[1] 279 randomized to MBTS, but 3 did not have a Norwood surgery; one was withdrawn-with limited data.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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MBTS Blalock-Taussig pulmonary artery shunt
RVPAS Right ventricular to pulmonary artery shunt
Total Total of all reporting groups

Baseline Measures
   MBTS   RVPAS   Total 
Overall Participants Analyzed 
[Units: Participants]
 275   274   549 
Age 
[Units: Participants]
     
<=18 years   275   274   549 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Days]
Mean (Standard Deviation)
 5.1  (4.1)   5.0  (4.0)   5.1  (4.0) 
Gender 
[Units: Participants]
     
Female   107   102   209 
Male   168   172   340 
Region of Enrollment 
[Units: Participants]
     
United States   268   266   534 
Canada   7   8   15 


  Outcome Measures
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1.  Primary:   Proportion of Patients Who Died or Received a Heart Transplant   [ Time Frame: Measured at 12 months ]

2.  Secondary:   Proportion of Deaths or Heart Transplants 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 ]

3.  Secondary:   Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)   [ Time Frame: Measured post-Norwood, an average of 17 days post-Norwood ]

4.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA   [ Time Frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery ]

5.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA   [ Time Frame: Measured at 14 months of age ]

6.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA   [ Time Frame: Measured post-Norwood, an average of 17 days post-Norwood ]

7.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA   [ Time Frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery ]

8.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA   [ Time Frame: Measured at 14 months of age ]

9.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction   [ Time Frame: Measured post-Norwood, an average of 17 days post-Norwood ]

10.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction   [ Time Frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery ]

11.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction   [ Time Frame: Measured at 14 months of age ]

12.  Secondary:   Angiographic Findings: Left Pulmonary Artery Size   [ Time Frame: Measured pre-stage II surgery, on average 26 days prior to stage II palliation ]

13.  Secondary:   Angiographic Findings: Right Pulmonary Artery Size   [ Time Frame: Measured pre-stage II surgery, on average 26 days prior to stage II palliation ]

14.  Secondary:   Unintended Cardiovascular Interventional Procedures   [ Time Frame: From Randomization to 12 months ]

15.  Secondary:   Complications: Total Number Experienced During Norwood Hospitalization   [ Time Frame: Norwood Hospitalization, an average of 36 days ]

16.  Secondary:   Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge   [ Time Frame: From Norwood Discharge to Stage II discharge, an average of 4.2 months ]

17.  Secondary:   Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age   [ Time Frame: From Stage II Discharge to 14 Months of Age, an average of 8.9 months ]


  Serious Adverse Events
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Time Frame Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented.
Additional 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.

Reporting Groups
  Description
MBTS Blalock-Taussig pulmonary artery shunt
RVPAS Right ventricular to pulmonary artery shunt

Serious Adverse Events
    MBTS   RVPAS
Total, Serious Adverse Events     
# participants affected / at risk   146/275 (53.09%)   112/274 (40.88%) 
Blood and lymphatic system disorders     
Coagulation † 1     
# participants affected / at risk   1/275 (0.36%)   1/274 (0.36%) 
# events   1   1 
Hemorrhage/bleeding † 1     
# participants affected / at risk   4/275 (1.45%)   6/274 (2.19%) 
# events   4   6 
Cardiac disorders     
Cardiac arrhythmia † 1     
# participants affected / at risk   7/275 (2.55%)   9/274 (3.28%) 
# events   8   10 
Cardiac general † 1     
# participants affected / at risk   97/275 (35.27%)   63/274 (22.99%) 
# events   111   73 
Gastrointestinal disorders     
Gastrointestinal † 1     
# participants affected / at risk   3/275 (1.09%)   3/274 (1.09%) 
# events   3   3 
Infections and infestations     
Infection † 1     
# participants affected / at risk   7/275 (2.55%)   9/274 (3.28%) 
# events   7   9 
Metabolism and nutrition disorders     
Metabolic/laboratory † 1     
# participants affected / at risk   1/275 (0.36%)   2/274 (0.73%) 
# events   1   2 
Musculoskeletal and connective tissue disorders     
Musculoskeletal/soft tissue † 1     
# participants affected / at risk   1/275 (0.36%)   0/274 (0.00%) 
# events   1   0 
Nervous system disorders     
Neurology † 1     
# participants affected / at risk   5/275 (1.82%)   4/274 (1.46%) 
# events   6   4 
Renal and urinary disorders     
Renal/genitourinary † 1     
# participants affected / at risk   3/275 (1.09%)   3/274 (1.09%) 
# events   3   3 
Respiratory, thoracic and mediastinal disorders     
Pulmonary/upper respiratory † 1     
# participants affected / at risk   11/275 (4.00%)   11/274 (4.01%) 
# events   11   11 
Surgical and medical procedures     
Surgery/intra-operative injury † 1     
# participants affected / at risk   4/275 (1.45%)   4/274 (1.46%) 
# events   4   4 
Vascular disorders     
Vascular † 1     
# participants affected / at risk   35/275 (12.73%)   29/274 (10.58%) 
# events   36   29 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (Unspecified)




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


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