Heart Defects, Congenital Clinical Trial
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)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05330338 -
Genetics of Ventriculo-arterial Discordance
|
N/A | |
Withdrawn |
NCT03405636 -
Xeltis Pulmonary Valved Conduit Safety and Performance Study
|
N/A | |
Completed |
NCT02443662 -
Colloid Osmotic Pressure in Patients With Fontan Circulation
|
||
Terminated |
NCT02519335 -
Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation
|
Phase 1 | |
Completed |
NCT01835392 -
Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery
|
N/A | |
Completed |
NCT00371891 -
Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)
|
Phase 4 | |
Completed |
NCT03035552 -
CTICU Pacifier Activated Music Player and Mother's Voice
|
N/A | |
Recruiting |
NCT04581668 -
Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease
|
N/A | |
Enrolling by invitation |
NCT04866537 -
Evaluation of the Diagnostic Performance of Specialized Fetal Cardiac Ultrasound in the CPDPN - Arc Alpin Network
|
||
Completed |
NCT03049540 -
Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function
|
Phase 3 | |
Completed |
NCT02377674 -
Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
|
N/A | |
Completed |
NCT01679275 -
Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease
|
||
Terminated |
NCT00543309 -
Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
|
Phase 2 | |
Completed |
NCT03957512 -
Livet Skal Leves (A Life to Live)
|
||
Recruiting |
NCT06005428 -
Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
|
Phase 2 | |
Recruiting |
NCT02691689 -
Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions
|
N/A | |
Completed |
NCT02306057 -
Fluid Balance in Children Undergoing Fontan Surgery
|
N/A | |
Recruiting |
NCT02157597 -
NIRS Guidance Trail in Children's Heart Surgery
|
N/A | |
Completed |
NCT01570933 -
Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.
|
Phase 4 | |
Completed |
NCT00443599 -
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
|
N/A |