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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 is a NA study that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 1 participants.

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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.

Interventions

  • PROCEDURE PVR

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2018-07-06
Est. Completion 2021-01-16
Phase NA

Sponsor

Children's Hospital of Philadelphia

431 total trials

What the Registry Record Tells You About NCT03634072

The ClinicalTrials.gov registry entry for NCT03634072 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which PVR is the first listed.

NCT03634072 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.