Left Bundle Branch Area Pacing 3D Guidance System

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461715
• Other study ID #: 333704
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Aldo Rinaldi, MD, MBBS, FRCP, FHRS
• Phone: 0207 188 9275
• Email: aldo.rinaldi[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Heart Failure

Intervention

Other:
• Machine 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.

Locations

Country	Name	City	State
United Kingdom	Imperial College Nhs Healthcare Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months