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NCT03634072 · ClinicalTrials.gov registry record · NA
Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -
A NA study, sponsored by Children's Hospital of Philadelphia.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT03634072: Clinical Trial NA study, sponsored by Children's Hospital of Philadelphia.
NCT03634072 is a NA study that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03634072, a NA study, was terminated before completion, sponsored by Children's Hospital of Philadelphia.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect with the vast majority of survivors of corrective surgery left with some degree of right ventricular (RV) volume overload due to pulmonary regurgitation (PR) which cause RV enlargement with right heart failure, diminished biventricular function, ventricular arrhythmia, sudden death and decreased exercise performance over time. Pulmonary valve replacement (PVR) has been thought to ameliorate these complications but the timing of replacement has yet to be determined with equipoise at the moment in this decision making process. As nearly all studies in this regard are retrospective with much less data in pediatric TOF than adults, this pilot trial sets the stage to create a prospective randomized trial in the teenage years.
Primary Outcome
Participants will be randomized by computer by the statistician at the Data Coordinating Center (DCC) at Northwestern University (NU) who will maintain the schedule; this will be a 2:1 randomization of PVR to no-PVR. There will be no blinding and the assignment will not be concealed from the investigators. There will be no stratifications within each group.
Interventions
- PROCEDURE PVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-07-06 |
| Est. Completion | 2021-01-16 |
| Phase | NA |
Why NCT03634072 stopped before completion
NCT03634072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which PVR is the first listed.
NCT03634072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03634072 about?
NCT03634072 is a clinical study titled "Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -". Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect with the vast majority of survivors of corrective surgery left with some degree of right ventricular (RV) volume overload due to pulmonary regurgitation (PR) which cause RV enlargement with right heart failure, diminished ...
What is the current status of trial NCT03634072?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2018-07-06. Estimated completion is 2021-01-16.
What interventions are being tested in trial NCT03634072?
The interventions under investigation include: PVR (PROCEDURE).
Who is sponsoring clinical trial NCT03634072?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03634072's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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
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