Left Bundle Branch Area Pacing 3D Guidance System

Not yet recruiting

• Conditions: Left Bundle Branch Pacing; Bradycardia; Heart Failure
• Interventions: Other: Machine learning with artificial intelligence software program

• Registration Number: NCT06461715
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

The investigator's 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 Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-17
• Last Update Posted: 2024-06-17
• Study Start: 2024-07-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• All patients who took part in the TACTIC-CRT (IRAS 250715) and Cardiac CT to guide Cardiac Resynchronisation Therapy (CRT) implantation (IRAS 150161) study.
• All patients who received a LBBA pacing device from the GSTT/RBH/ICH database in the last 10 years (from 01/01/2014) and had a cardiac MRI for assessment of scar.
• All patients who are >18 years old.
• Male and Female

Exclusion Criteria

• All patients <18 years old
• Patients with congenital heart disease
• Patients who did not have a cardiac MRI before receiving a LBBA pacing device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Left bundle branch pacing group	Machine learning with artificial intelligence software program	Patients who underwent left bundle branch pacing

Primary Outcome Measures

Name	Time	Method
Detection of the position of the left bundle branch area on x-ray fluoroscopy	12 months	The accuracy of left bundle branch area detection will be measured as intersection-over-union (IoU) with the use of a convolutional neural network

Trial Locations

Locations (1)

Imperial College Nhs Healthcare Trust; 🇬🇧 London, United Kingdom