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

This study has been completed.
Sponsor:
Collaborators:
Pediatric Heart Network
Information provided by:
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00115934
First received: June 26, 2005
Last updated: August 2, 2013
Last verified: August 2013
Results First Received: September 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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[1] 279 randomized to MBTS, but 3 did not have a Norwood surgery; one was withdrawn-with limited data.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  
Number of Participants  
[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 ]
  Hide Outcome Measure 14

Measure Type Secondary
Measure Title Unintended Cardiovascular Interventional Procedures
Measure 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  
Safety Issue Yes  

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

Measured Values
    MBTS     RVPAS  
Number of Participants Analyzed  
[units: participants]
  275     274  
Unintended Cardiovascular Interventional Procedures  
[units: procedures]
  192     252  


Statistical Analysis 1 for Unintended Cardiovascular Interventional Procedures
Groups [1] All groups
Method [2] Poisson regression
P Value [3] 0.003
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The offset parameter used in the poisson regression was the log of the number of patients in each treatment arm.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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


  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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