Left Bundle Branch Area Pacing 3D Guidance System

NCT06461715 | Not Yet Recruiting

• 1 other identifier: 333704
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Bundle Branch Pacing; Heart Failure; Bradycardia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Left bundle branch pacing group

Patients who underwent left bundle branch pacing

Other: Machine learning with artificial intelligence software program

Interventions

Machine learning with artificial intelligence software program OTHER

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.

Left bundle branch pacing group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Imperial College Nhs Healthcare Trust

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Bradycardia

Interventions

Machine Learning

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Artificial Intelligence; Algorithms; Mathematical Concepts

Central Study Contacts

Aldo Rinaldi, MD, MBBS, FRCP, FHRS

CONTACT

0207 188 9275; aldo.rinaldi@gstt.nhs.uk

Sandra Howell, MBBS, MSc, MSc

CONTACT

0207 188 9275; sandra.howell@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 17, 2024
• Study Start: July 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)