Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636851
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Effect of Site of Right Ventricular RV Pacing on RV Function Left Ventricular LV Dyssynchrony and Contraction Efficiency
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Site of Right Ventricular RV Pacing on RV Function Left Ventricular LV Dyssynchrony and Contraction Efficiency
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate RV systolic function and LV mechanical dyssynchrony and function in different lead position in the RV during permanent pacemaker implantation by using speckle tracking echocardiography STE and 3D volumetric ejection fraction
Detailed Description:
Permanent pacing with right ventricular stimulation is the standard method used in patients with bradyarrhythmia and recommended by current international guidelines because it is associated with improved clinical outcomes The extent of right ventricular pacing RVP varies between patients and many individuals tolerate a high proportion of RVP without complications However chronic RVP may cause electrical and mechanical dyssynchrony that may lead to impaired left ventricular ejection fraction LVEF Dyssynchronous ventricles require more oxygen to generate the same amount of mechanical work and the consequence is a decline in the efficieny of myocardial contraction RV septal pacing RVS is thought to allow more physiological LV depolarisation than RV apical pacing RVA with preservation of LV function However there are conflicting data on its benefits and the recently completed Protect-Pace The protection of LV function during RV pacing study showed both RVA and non-RVA pacing to have a small adverse effect on EF in patients with preserved LV function but no difference between the methods The effect of RV pacing on RV function has not been evaluated systematically with most studies focusing on tricuspid regurgitation TR as the outcome of interest Echocardiographic assessment of LV dyssynchrony has been extensively used because it is noninvasive widely available and has no known risk or side effect Speckle tracking echocardiography is a novel echocardiographic technique without the angle dependence of an ultrasound beam and is able to measure regional deformation in any direction in the LV and RV that can detect subtle myocardial dysfunction because it is more sensitive compared with conventional parameters Furthermore strain imaging can display the timing and extent of myocardial thickening and stretching so that it is well suited to estimate the amount of inefficient dyssynchronous contraction Global Longitudinal Strain GLS and LV mechanical function and dyssynchrony assessment by speckle-tracking echocardiography STE enables us to detect subclinical LV dysfunction And also a very attractive clinical tool for the assessment of right ventricular RV systolic performance providing incremental diagnostic and prognostic information over the traditional indices of RV function Among various imaging modalities echocardiography is currently the method of choice for clinical assessment of RV longitudinal strain RVLS The methodology of speckle-tracking echocardiography to obtain RVLS has been recently standardized and demonstrated to be feasible accurate and robust for clinical use Inter-technique and inter-vendor comparability and reliability of RVLS are improving RVLS is advantageous because it is more sensitive to subtle changes in myocardial function than conventional parameters used to assess RV function ie tricuspid annular plane systolic excursion tissue Doppler systolic velocity fractional area change or RV ejection fraction representing a sensitive tool for the long-term follow-up of patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None