Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540521
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Bolt CSP-M Holter Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intracardiac Electrical Characteristics of LBBAP
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing LBBAP from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP
Detailed Description:
Among LBB area pacing LBBAP it has been reported that left ventricular LV septal pacing LVSP which refers to a pacing approach that only captures the LV septal myocardium produces homogeneous electrical propagation in the septum and leads to delayed LV lateral wall activation Although large randomized trials are lacking small observational studies have shown more preserved physiological ventricular depolarization or superior electrical and mechanical synchrony of the LBB capture over LVSP
During the implantation of a device the most commonly used method to distinguish LVSP from the LBB capture is to pace with different pacing outputs A transition will be found in the ECG morphology with changes in the LV activation time if the pacing capture threshold PCT of the local myocardium is different from that of the LBB ie LBB-PCT indicating a transition between capturing the LBB and LVSP without any LBB capture So far there is no systematic investigation on the EGM characteristics or correlation between ECG and EGM characteristics at different conduction system capture status Findings from this study will help to better characterize EGM characteristics and to develop an optimal LBBAP modality to differentiate LBB capture
During the implantation of a device the most commonly used method to distinguish LVSP from the LBB capture is to pace with different pacing outputs A transition will be found in the ECG morphology with changes in the LV activation time if the pacing capture threshold PCT of the local myocardium is different from that of the LBB ie LBB-PCT indicating a transition between capturing the LBB and LVSP without any LBB capture So far there is no systematic investigation on the EGM characteristics or correlation between ECG and EGM characteristics at different conduction system capture status Findings from this study will help to better characterize EGM characteristics and to develop an optimal LBBAP modality to differentiate LBB capture
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