Left Bundle Branch Area Pacing 3D Guidance System | NCT06461715

Studies
Left Bundle Branch Area Pacing 3D Guidance System

NCT06461715

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Status

Unknown status

Last Update Posted

Jun 17, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Left Bundle Branch Pacing
Heart Failure
Bradycardia

Interventions

Machine learning with artificial intelligence software program

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Estimated

Primary Completion Date

May 31, 2025Estimated

Completion Date

May 31, 2025Estimated

First Submitted Date

Jun 5, 2024

First Submission Date that Met QC Criteria

Jun 14, 2024

First Posted Date

Jun 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2024

Last Update Posted Date

Jun 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Left bundle branch pacing group		Patients who underwent left bundle branch pacing	Other: Machine learning with artificial intelligence software program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imperial College Nhs Healthcare Trust		London		W12 0HS	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D001919	Bradycardia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069550	Machine Learning

Ancestor Terms

ID	Term
D001185	Artificial Intelligence
D000465	Algorithms
D055641	Mathematical Concepts

Browse Leaves

Not provided

Browse Branches

Not provided