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

Carelon Research

Status and phase

Completed

Phase 3

Conditions

Heart Defects, Congenital

Treatments

Procedure: Right ventricular to pulmonary artery shunt

Procedure: Blalock-Taussig pulmonary artery shunt

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00115934

194

U01HL068292 (U.S. NIH Grant/Contract)

U01HL068270 (U.S. NIH Grant/Contract)

U01HL068290 (U.S. NIH Grant/Contract)

U01HL068288 (U.S. NIH Grant/Contract)

U01HL068281 (U.S. NIH Grant/Contract)

U01HL068269 (U.S. NIH Grant/Contract)

U01HL068285 (U.S. NIH Grant/Contract)

U01HL068279 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

BACKGROUND:

Hypoplastic left heart syndrome (HLHS) and related single right ventricle anomalies are the highest risk congenital cardiovascular malformations. Surgical repair begins with the Norwood procedure during the newborn period, a stage II procedure at 4 to 6 months of age, and Fontan procedure at 18 to 36 months. The Norwood procedure remains one of the highest risk procedures in congenital heart surgery. A few small nonrandomized studies of a novel approach to the Norwood procedure have reported improved outcomes. This new approach uses a RV-to-PA shunt to provide pulmonary blood flow rather than the standard MBTS. This multi-center, randomized clinical trial will evaluate early and intermediate-term outcomes for patients undergoing a Norwood procedure with either the RV-to-PA shunt or the MBTS.

This study has been approved by the Institutional Review/Research Ethics Boards of all participating clinical centers:

Hospital for Sick Children, Toronto, Canada

Children's Hospital Boston, Boston, MA

Columbia College of Physicians and Surgeons, New York, NY

Children's Hospital of Philadelphia, Philadelphia, PA

Duke University Medical Center, Durham, NC

Brody School of Medicine at East Carolina University, Greenville, NC

Wake Forest Baptist Medical Center, Winston Salem, NC

Medical University of South Carolina, Charleston, SC

Children's Hospital of Wisconsin, Milwaukee, WI

University of Michigan, Ann Arbor, MI

Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Children's Hospital of Los Angeles, Los Angeles, CA

Egleston Children's Hospital, Emory University, Atlanta, GA

Congenital Heart Institute of Florida, University of South Florida, St. Petersburg, FL

Alfred I. duPont Hospital for Children, Wilmington, DE

DESIGN NARRATIVE:

This is a prospective, randomized clinical trial of the RV-to-PA shunt versus MBTS in patients undergoing a Norwood procedure.

Enrollment

555 patients

Sex

All

Volunteers

No Healthy Volunteers

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