Left Bundle Branch Area Pacing 3D Guidance System

Left Bundle Branch Area Pacing Study Designing the 3D Hybrid Guidance System for Implantation of Cardiac Devices

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06461715

Enrollment

300

Registered

2024-06-17

Start date

2024-07-01

Completion date

2025-05-31

Last updated

2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia, Heart Failure, Left Bundle Branch Pacing

Keywords

Left bundle branch pacing, Pacemaker, Artificial intelligence, Conduction system pacing

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.

Interventions

OTHERMachine learning with artificial intelligence software program

This is a retrospective observational study using cardiac MRI, cardiac CT and x-ray fluoroscopy images to develop a 3D hybrid guidance system with the use of deep learning methods.

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United Kingdom

Contacts

Primary ContactAldo Rinaldi, MD, MBBS, FRCP, FHRS

aldo.rinaldi@gstt.nhs.uk0207 188 9275

Backup ContactSandra Howell, MBBS, MSc, MSc

sandra.howell@kcl.ac.uk0207 188 9275

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026