Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Boston Children's Hospital.
NCT00112320 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 68 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00112320 record still lists
NCT00112320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which PVR plus RV remodeling is the first listed.
NCT00112320 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00112320's enrollment target sits among peer trials
68 1133rd of 2000 higher than 862 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
- NCT02044497 · 68 participants · Phase 4
Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients
- NCT03779854 · 68 participants · Phase 2
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
- NCT03821246 · 68 participants · Phase 2
Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
- NCT04115514 · 68 participants · Phase 2
Treatment of ARDS With Instilled T3
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