Clinical trial NCT06461715: Left Bundle Branch Area Pacing 3D Guidance System
Official title: Left Bundle Branch Area Pacing Study Designing the 3D Hybrid Guidance System for Implantation of Cardiac Devices
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Left Bundle Branch Pacing
Heart Failure
Bradycardia
Keywords: Left bundle branch pacing
Pacemaker
Artificial intelligence
Conduction system pacing
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of the position of the left bundle branch area on x-ray fluoroscopy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Nhs Healthcare Trust
Study officials:
References: