Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03634072
Status:
TERMINATED
Last Update Posted:
2023-10-06
First Post:
2018-08-02
Brief Title:
Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot - The PREPARE-TOF Study
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to meet enrollment goal
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOFandPVR
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34HL142142-01 | NIH | None | httpsreporternihgovquickSearchR34HL142142-01 |