Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The purpose of this research study is to gather information on adolescents and young adults to help understand and improve the lives of patients with TOF. Some patients diagnosed with TOF will have a procedure called pulmonary valve replacement (PVR) and some will not. PVR is done for valves that are too damaged to be repaired. This requires a surgeon or an expert in a procedure called cardiac catheterization to replace the damaged pulmonary valve with a valve made of tissue or a mechanical valve. Multiple studies in adult TOF patients have suggested that PVR may lessen many clinical symptoms but no one is sure if it truly does. There is little information about PVR in adolescence but it is thought that lessening the amount of leakage of the pulmonary valve at a young age may avoid future complications such as right heart failure or abnormal beats of your heart. There is no agreement among cardiologists, surgeons or other healthcare providers as to whether PVR truly helps avoid complications in the future and if it does, when PVR should be done. Using the information in this study, we hope to find out if PVR in adolescents is helpful in both the short and long term. The Investigators believe the results of this study will help provide doctors with enough information to support a future large scale research study to further evaluate the outcomes PVR. This study will involve randomization to either the PVR or no PVR cohort, medical records review, exercise test and Cardiac Magnetic Resonance (CMR) , and questionnaires. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03634072
Study type Interventional
Source Children's Hospital of Philadelphia
Contact
Status Terminated
Phase N/A
Start date July 6, 2018
Completion date January 16, 2021

See also
  Status Clinical Trial Phase
Completed NCT02534792 - Early Revalvulation After Fallot Repair Improves Clinical Outcome N/A
Completed NCT00536432 - Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot N/A
Not yet recruiting NCT05485545 - Asynchrony in Operated Tetralogy of Fallot N/A
Completed NCT01941576 - Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot N/A
Active, not recruiting NCT03983512 - PULSTA Transcatheter Pulmonary Valve Pre-Approval Study N/A
Recruiting NCT04581668 - Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease N/A
Completed NCT01762124 - Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV) N/A
Active, not recruiting NCT02161471 - Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance
Not yet recruiting NCT05916976 - Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment N/A
Recruiting NCT04106479 - NIRS in Congenital Heart Defects - Correlation With Echocardiography
Completed NCT05579964 - The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot Phase 2/Phase 3
Recruiting NCT05236153 - Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot N/A
Recruiting NCT03049995 - Stress Echo 2020 - The International Stress Echo Study
Completed NCT02586740 - Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation N/A
Terminated NCT00564993 - Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot Phase 3
Recruiting NCT05122962 - Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
Completed NCT06097377 - Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study
Completed NCT03835494 - Analysis of RV-Dysfunction in Fallot Patients N/A
Not yet recruiting NCT03275844 - Physical Capacity and Activity in Children With Congenital Heart Disease N/A
Recruiting NCT02590679 - Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p Phase 2/Phase 3