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

NCT00115934 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2025-03-11

Study results available
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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.

Conditions

  • Heart Defects, Congenital

Interventions

PROCEDURE

Blalock-Taussig pulmonary artery shunt

Performed at stage I palliative surgery for babies born with HLHS

PROCEDURE

Right ventricular to pulmonary artery shunt

Performed at stage I palliative surgery for babies born with HLHS

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Pediatric Heart Network

    collaborator OTHER

  • Carelon Research

    lead OTHER

Principal Investigators

  • Julie E Miller, MPH · New England Research Institutes, Watertown, MA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-09-30
Completion
2009-10-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00115934 on ClinicalTrials.gov