Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -

Stopped early · Not applicable

Conditions studied: Tetralogy of Fallot

In brief

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.

Key facts

Study ID

NCT03634072

Run by

Children's Hospital of Philadelphia

People needed

1

Starts

2018-07-06

Expected to finish

2021-01-16

Last updated by the study team

2023-10-06

Who can join

Age: 13 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females with repaired Tetralogy of Fallot (TOF), currently between 13 and 21 years of age.
• On clinical Cardiac Magnetic Resonance (CMR) : Right Ventricular End-Diastolic Volume Index (RVEDVi) between 140 and 180 cc/m2 inclusive with Right Ventricular End-Diastolic Function (RVEF) > 40% and Left Right Ventricular End-Diastolic (LVEF ) > 50%, RV outflow tract peak velocity < 3 meters/second (if not available this will be skipped); there will be no indexed Right Ventricular end-systolic volume (RVESVi) criteria; by defining RVEDVi and RVEF, Investigators will be inherently defining RVESVi
• On clinical echocardiogram: RV outflow tract peak velocity < 3 meters/second (if not available this will be skipped), at least mild pulmonary insufficiency and tricuspid regurgitation with an RV pressure estimate < 1/2 systemic pressure.
• On Exercise Stress Test (EST), aerobic capacity > 60% of predicted.
• No Q-wave, R-wave, S-wave (QRS) duration criteria on ECG.

You may not qualify if…

• Any condition judged by the patient's physician that would cause this trial to be detrimental to the patient.
• Specific forms of TOF excluded are those with endocardial cushion defects, TOF with absent pulmonary valve and TOF with multiple aorto-pulmonary collaterals requiring unifocalization.
• Unilateral branch pulmonary artery stenosis (one lung receives < 25% of total flow)
• Contraindication to non-sedated exercise CMR (e.g. pacemaker/implanted cardioverter defibrillator); need for sedation
• If data available, moderate or greater tricuspid regurgitation on echocardiogram or CMR or Qp/Qs > 1.5
• Significant strokes/hemiplegia or inability to exercise
• Genetic syndrome/developmental delay which would make QOL and EST date uninterpretable
• Pregnancy
• Previous pulmonary valve replacement (PVR)

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• Cincinnati Children's Hosptial Medical Center — Cincinnati, Ohio, United States
• The Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.