Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT00115934
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2005-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
Sponsor:
Carelon Research
Organization:
Study Overview
Official Title:
Trial of Right Ventricular Versus Modified Blalock-Taussig Shunt in Infants With Single Ventricle Defect Undergoing Staged Reconstruction (A Trial Conducted by the Pediatric Heart Network)
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01HL068270 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01HL068269 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01HL068279 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01HL068281 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01HL068285 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01HL068288 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01HL068290 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01HL068292 | NIH | None | https://reporter.nih.gov/quic… | View |