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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 is a NA study that has completed, run by Carelon Research. The registered enrollment target is 555 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00115934
The ClinicalTrials.gov registry entry for NCT00115934 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 555 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 50 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Blalock-Taussig pulmonary artery shunt is the first listed.
NCT00115934 reports 0 study locations.
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.
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