Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
Heart Defects, Congenital
About this trial
This is an interventional treatment trial for Heart Defects, Congenital
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
Sites / Locations
- Children's Hospital of Los Angeles
- Alfred I. duPont Hospital for Children
- Cardiac Surgical Associates
- Children's Healthcare of Atlanta at Egleston
- Children's Hospital Boston
- University of Michigan Health System/Mott Hospital
- Columbia College of Physicians and Surgeons
- Duke University Medical Center
- Cincinnati Children's Hospital Medical Center
- Children's Hospital of Philadelphia
- Medical University of South Carolina
- Children's Hospital of Wisconsin
- Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
MBTS
RVPAS
Blalock-Taussig pulmonary artery shunt
Right ventricular to pulmonary artery shunt