Recruitment

Recruitment Status
Completed
Estimated Enrollment
106

Inclusion Criterias

Diagnosis of: D-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of Fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent ductus arteriosus)
Scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary bypass.
Male or female, age 0 to 180 days at the time of surgery.
Diagnosis of: D-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of Fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent ductus arteriosus)
Scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary bypass.
Male or female, age 0 to 180 days at the time of surgery.

Summary

Conditions
  • Tetralogy of Fallot
  • Transposition of the Great Arteries
  • Ventricular Septal Defect
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 180 years
Gender
Both males and females

Inclusion Criterias

Diagnosis of: D-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of Fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent ductus arteriosus)
Scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary bypass.
Male or female, age 0 to 180 days at the time of surgery.
Diagnosis of: D-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of Fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent ductus arteriosus)
Scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary bypass.
Male or female, age 0 to 180 days at the time of surgery.

Locations

Houston, Texas, 77030
Boston, Massachusetts, 02111
Ann Arbor, Michigan, 48109
Philadelphia, Pennsylvania, 19104
...
Houston, Texas, 77030
Boston, Massachusetts, 02111
Ann Arbor, Michigan, 48109
Philadelphia, Pennsylvania, 19104

Tracking Information

NCT #
NCT01915277
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Not Provided