Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115934
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2005-06-26
Brief Title:
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
Sponsor:
Carelon Research
Organization:
Carelon Research
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 ReviewResearch Ethics Boards of all participating clinical centers
Hospital for Sick Children Toronto Canada
Childrens Hospital Boston Boston MA
Columbia College of Physicians and Surgeons New York NY
Childrens 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
Childrens Hospital of Wisconsin Milwaukee WI
University of Michigan Ann Arbor MI
Cincinnati Childrens Hospital Medical Center Cincinnati OH
Childrens Hospital of Los Angeles Los Angeles CA
Egleston Childrens 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 ReviewResearch Ethics Boards of all participating clinical centers
Hospital for Sick Children Toronto Canada
Childrens Hospital Boston Boston MA
Columbia College of Physicians and Surgeons New York NY
Childrens 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
Childrens Hospital of Wisconsin Milwaukee WI
University of Michigan Ann Arbor MI
Cincinnati Childrens Hospital Medical Center Cincinnati OH
Childrens Hospital of Los Angeles Los Angeles CA
Egleston Childrens 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL068292 | NIH | None | httpsreporternihgovquickSearchU01HL068292 |
| U01HL068270 | NIH | None | None |
| U01HL068269 | NIH | None | None |
| U01HL068279 | NIH | None | None |
| U01HL068281 | NIH | None | None |
| U01HL068285 | NIH | None | None |
| U01HL068288 | NIH | None | None |
| U01HL068290 | NIH | None | None |