N/A N=555 Randomized Treatment

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

Heart Defects, Congenital

Bottom Line

View on ClinicalTrials.gov: NCT00115934 ↗

Enrolled (actual)

555

Serious AEs

47.0%

Results posted

Jun 2011

Primary outcome: Primary: Proportion of Patients Who Died or Received a Heart Transplant — 100; 72 Participants — p=0.013

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Blalock-Taussig pulmonary artery shunt (Procedure); Right ventricular to pulmonary artery shunt (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Carelon Research
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients Who Died or Received a Heart Transplant	100; 72	0.013 sig
SECONDARY Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial	107; 88	0.06
SECONDARY Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)	91.2; 86.5	0.09
SECONDARY Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA	83.3; 88.9	0.07
SECONDARY Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA	83.3; 88.9	0.07
SECONDARY Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA	45.4; 50.5	0.10
SECONDARY Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA	45.4; 50.5	0.10
SECONDARY Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA	45.4; 50.5	0.10
SECONDARY Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction	42.7; 42.7	0.97
SECONDARY Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction	42.7; 42.7	0.97
SECONDARY Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction	42.7; 42.7	0.97
SECONDARY Angiographic Findings: Left Pulmonary Artery Size	5.2; 5.4	0.54
SECONDARY Angiographic Findings: Right Pulmonary Artery Size	6.1; 5.4	<0.001 sig
SECONDARY Unintended Cardiovascular Interventional Procedures	192; 252	0.003 sig
SECONDARY Complications: Total Number Experienced During Norwood Hospitalization	850; 792	0.20
SECONDARY Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge	367; 515	0.002 sig
SECONDARY Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age	81; 145	0.03 sig

Summary

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.

Eligibility Criteria

Inclusion Criteria

Diagnosis of hypoplastic left heart syndrome or related single, morphologic right ventricle anomaly
Planned Norwood procedure
Informed consent of parent(s) or legal guardian

Exclusion Criteria

Single, morphologic left ventricle anomaly
Preoperative identification of anatomy rendering either an MBTS or an RV-to-PA shunt technically impossible
Any major congenital abnormality (i.e., congenital diaphragmatic hernia, tracheoesophageal fistula) or acquired extra-cardiac disorder (e.g., meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis) that, in the opinion of the investigator, could independently affect the likelihood of the subject meeting the primary endpoint

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00115934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.