Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06282926
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-08-10
Brief Title:
Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Role of Three-dimensional Echocardiography Knowledge-based Reconstruction in Monitoring Right Ventricle Remodelling Following Tetralogy of Fallot Repair
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair
As part of the validation study the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers Additionally TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice such as tricuspid annular plane systolic excursion TAPSE tissue Doppler imaging TDI fractional area change FAC and global longitudinal strain GLS
Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements particularly with GLS
The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase
As part of the validation study the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers Additionally TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice such as tricuspid annular plane systolic excursion TAPSE tissue Doppler imaging TDI fractional area change FAC and global longitudinal strain GLS
Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements particularly with GLS
The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase
Detailed Description:
Tetralogy of Fallot ToF is a complex pathophysiology characterised by different factors that affect the right ventricle RV performance Before surgical repair in childhood the RV is exposed to pressure load with associated abnormal RV outflow tract RVOT hypertrophy and myocardial damage related to prolonged cyanosis After surgical repair involving a pulmonary valve PV transannular patch the RV may experience chronic volume overload due to significant pulmonary regurgitation PR The effects of chronic volume overload often found in adult congenital heart disease ACHD patients frequently result in progressive RV dilatation with abnormal geometry and RV dysfunction with associated electromechanical dyssynchrony All this often leads to re-intervention with PV replacement In asymptomatic patients with severe PR the 2020 European ACHD guidelines recommendation for PV replacement gives a class 2a recommendation and evidence level C in cases of progressive RV systolic dysfunction andor dilatation with a RV indexed end-diastolic volume EDVi 160 mLm2 andor a RV indexed end-systolic volume ESVi 80 mLm2 The guidelines also mentioned gaps regarding the need for more longitudinal imaging data to optimise time for re-intervention because the possibility for RV remodelling is at some point irreversible
CMR is widely recognised in the literature as the reference standard imaging technique for accurately quantifying RV volume and ejection fraction EF in the ACHD population However unlike transthoracic echocardiography TTE CMR is not the first-line test used in daily clinical practice
The echocardiographic requirement of conventional multiple non-geometric tricuspid annular plane systolic excursion tissue Doppler imaging global longitudinal strain and geometric two-dimensional 2D parameters fractional area change three-dimensional volume and EF for a more accurate RV size and systolic function assessment is consensual in the literature with global longitudinal strain GLS emerging as a simple and effective tool for the management of repaired ToF patients Also it is known that conventional three-dimensional 3D echocardiography systematically underestimates RV volumes and overestimates EF Therefore CMR and conventional 3D echo should not be used interchangeably
Alternatively 3D knowledge-based reconstruction derived from 2D echocardiography TTE-3DKBR has shown to be a valuable tool for RV volume and EF assessment that can complement CMR and maximise the available resources in clinical practice The literature on TTE-3DKBR in children and adults with ToF indicates a high correlation with CMR and its potential for clinical follow-up in repaired ToF patients may be relevant However the recommendations of the expert consensus documents are also clear that further validation studies are needed before its implementation in clinical practice
The current longitudinal study aims to further the role of TTE-3DKBR in evaluating the effects of chronic RV volume overload in ACHD repaired ToF patients by assessing its reproducibility and accuracy against CMR and conventional echocardiography measurements particularly with standard GLS
CMR is widely recognised in the literature as the reference standard imaging technique for accurately quantifying RV volume and ejection fraction EF in the ACHD population However unlike transthoracic echocardiography TTE CMR is not the first-line test used in daily clinical practice
The echocardiographic requirement of conventional multiple non-geometric tricuspid annular plane systolic excursion tissue Doppler imaging global longitudinal strain and geometric two-dimensional 2D parameters fractional area change three-dimensional volume and EF for a more accurate RV size and systolic function assessment is consensual in the literature with global longitudinal strain GLS emerging as a simple and effective tool for the management of repaired ToF patients Also it is known that conventional three-dimensional 3D echocardiography systematically underestimates RV volumes and overestimates EF Therefore CMR and conventional 3D echo should not be used interchangeably
Alternatively 3D knowledge-based reconstruction derived from 2D echocardiography TTE-3DKBR has shown to be a valuable tool for RV volume and EF assessment that can complement CMR and maximise the available resources in clinical practice The literature on TTE-3DKBR in children and adults with ToF indicates a high correlation with CMR and its potential for clinical follow-up in repaired ToF patients may be relevant However the recommendations of the expert consensus documents are also clear that further validation studies are needed before its implementation in clinical practice
The current longitudinal study aims to further the role of TTE-3DKBR in evaluating the effects of chronic RV volume overload in ACHD repaired ToF patients by assessing its reproducibility and accuracy against CMR and conventional echocardiography measurements particularly with standard GLS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None