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NCT00112320 · ClinicalTrials.gov registry record · NA
Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 68
- Enrollment target
NCT00112320 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 68 participants.
The verdict
NCT00112320, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
Study Summary
Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. This procedure often leads to regurgitation (leakage) of the pulmonary valve, which puts the burden of handling a larger than normal amount of blood flow on the RV. Over the years, that extra burden leads to enlargement of the RV and to a decrease in its function. Treatment often includes surgical insertion or replacement of a new pulmonary valve. Replacement of the damaged pulmonary valve aims to minimize the leakage and help the RV function better. This study is designed to compare two methods of how the operation (called pulmonary valve replacement \[PVR\]) is performed. In the first method, a new valve is inserted and only the area of the old valve is operated on; this is the standard PVR. The second method involves inserting the new valve in the same way as the standard method but, in addition, areas of the right ventricular wall that are scarred and not functioning well are removed (PVR plus right ventricular remodeling). This study will evaluate which method is more effective based on the size and function of the RV measured by cardiac magnetic resonance imaging (CMR) six months following surgery, as compared to its size and function before the operation.
Interventions
- PROCEDURE PVR plus RV remodeling
- PROCEDURE Standard PVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2004-04 |
| Est. Completion | 2011-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00112320
The ClinicalTrials.gov registry entry for NCT00112320 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PVR plus RV remodeling is the first listed.
NCT00112320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00112320 about?
NCT00112320 is a clinical study titled "Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot". Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. This procedure often leads to regurgitat...
What is the current status of trial NCT00112320?
This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2004-04. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00112320?
The interventions under investigation include: PVR plus RV remodeling (PROCEDURE), Standard PVR (PROCEDURE).
Who is sponsoring clinical trial NCT00112320?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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