Left Bundle Branch Area Pacing 3D Guidance System

ConditionsLeft Bundle Branch Pacing Heart Failure Bradycardia

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

All patients <18 years old

Patients with congenital heart disease

Patients who did not have a cardiac MRI before receiving a LBBA pacing device

Trial population

Anonymised images from patients who took part in the TACTIC-CRT (IRAS 250715) and Cardiac CT to guide Cardiac Resynchronisation Therapy (CRT) implantation (IRAS 150161) or who received left bundle branch pacing and had a cardiac MRI

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

Machine learning with artificial intelligence software program
Other intervention
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.

Treatment groups

300 Participants

are divided into 1 treatment group

Group A: Left bundle branch pacing group1 intervention

Trial outcomes

Primary outcomes

Detection of the position of the left bundle branch area on x-ray fluoroscopy

The accuracy of left bundle branch area detection will be measured as intersection-over-union (IoU) with the use of a convolutional neural network

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: