Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461715
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-05
Brief Title:
Left Bundle Branch Area Pacing 3D Guidance System
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Left Bundle Branch Area Pacing Study Designing the 3D Hybrid Guidance System for Implantation of Cardiac Devices
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 investigators project proposes the development of a 3D hybrid guidance system which has the aim of avoidance of scar and septal perforation through targeted lead deployment via a personalised septal real time image overlay onto x-ray fluoroscopy imaging during left bundle branch pacing The investigators hypothesise that the use of cardiac anatomy and myocardial scar distribution derived from cardiac magnetic resonance imaging MRI as well as 3D position of the pacing lead may improve LBBAP lead deployment success and improve clinical outcomes by guiding the physician towards optimal lead positioning
Detailed Description:
The study will use anonymised imaging data from the TACTIC-CRT IRAS 250715 Cardiac CT to guide Cardiac Resynchronisation Therapy CRT implantation IRAS 150161 study IRAS 150161 and anonymous cardiac MRI CT and fluoroscopy imaging data from patients who underwent LBBA pacing to develop a 3D hybrid guidance system using machine learning methods The developed 3D hybrid guidance system will be tested on anonymised retrospectively collected x-ray fluoroscopy images from patients who underwent LBBAP and had a cardiac MRI The 3D hybrid guidance system will collect data from the retrospective anonymised X-ray fluoroscopic images detect the pacing lead and reconstruct the 3D position of the pacing lead and test the accuracy of the 3D hybrid guidance system
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