Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00115934 · ClinicalTrials.gov registry record · NA
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
A NA study, sponsored by Carelon Research.
- Completed
- Registry status
- NA
- Development phase
- 555
- Enrollment target
NCT00115934: Completed NA study, sponsored by Carelon Research.
NCT00115934 is a NA study that has completed, run by Carelon Research. The registered enrollment target is 555 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00115934, a NA study, has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 555 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.
Interventions
- PROCEDURE Blalock-Taussig pulmonary artery shunt
- PROCEDURE Right ventricular to pulmonary artery shunt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 555 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-10 |
| Phase | NA |
What the finished NCT00115934 record still lists
NCT00115934 is an interventional study that assigns participants to a tested intervention. The registered 555 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Blalock-Taussig pulmonary artery shunt is the first listed.
NCT00115934 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00115934 about?
NCT00115934 is a clinical study titled "Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--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 rand...
What is the current status of trial NCT00115934?
This trial is currently completed. It is a NA study. The enrollment target is 555 participants. The study started on 2005-05. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00115934?
The interventions under investigation include: Blalock-Taussig pulmonary artery shunt (PROCEDURE), Right ventricular to pulmonary artery shunt (PROCEDURE).
Who is sponsoring clinical trial NCT00115934?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00115934's enrollment target sits among peer trials
555 184th of 2000 higher than 1,817 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06799000 · 555 participants · Phase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
- NCT06840392 · 555 participants · Phase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
- NCT06074588 · 556 participants · Phase 3
Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
- NCT06693622 · 556 participants
Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia