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

Completed · Not applicable

Conditions studied: Heart Defects, Congenital

In brief

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.

Key facts

Study ID

NCT00115934

Run by

Carelon Research

People needed

555

Starts

2005-05-01

Expected to finish

2009-10-01

Last updated by the study team

2025-03-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Cardiac Surgical Associates — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• University of Michigan Health System/Mott Hospital — Ann Arbor, Michigan, United States
• Columbia College of Physicians and Surgeons — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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