Left Bundle Branch PacingNCT06461715
Left Bundle Branch Area Pacing 3D Guidance System
An observational study of Left Bundle Branch Pacing and Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Bundle Branch Pacing, Heart Failure, Bradycardia
- What is being tested?
- Machine learning with artificial intelligence software program
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Nhs Healthcare Trust
London, W12 0HS
Steven Niederer, MPhil, PhD, s.niederer@imperial.ac.uk
About this study
Official title: Left Bundle Branch Area Pacing Study Designing the 3D Hybrid Guidance System for Implantation of Cardiac Devices
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.
Read the 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.
- Conditions
- Left Bundle Branch Pacing, Heart Failure, Bradycardia
- Being tested
- Machine learning with artificial intelligence software program
- Keywords
- Left bundle branch pacing, Pacemaker, Artificial intelligence, Conduction system pacing
- Medical subject headings
- Heart Failure, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine learning with artificial intelligence software programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Left bundle branch pacing group | Patients who underwent left bundle branch pacing Receives: Other: Machine learning with artificial intelligence software program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Bundle Branch PacingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461715
- Sponsor's protocol ID
- 333704
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Area Pacing Study Designing the 3D Hybrid Guidance System for Implantation of Cardiac Devices
- ClinicalTrials.gov ID
- NCT06461715
- Acronym / sponsor ID
- 333704
- Conditions
- Left Bundle Branch Pacing, Heart Failure, Bradycardia
- Keywords
- Left bundle branch pacing, Pacemaker, Artificial intelligence, Conduction system pacing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left bundle branch pacing group | – | Other: Machine learning with artificial intelligence software programPatients who underwent left bundle branch pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- All patients <18 years old
- Patients with congenital heart disease
- Patients who did not have a cardiac MRI before receiving a LBBA pacing device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Machine learning with artificial intelligence software programThis 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. | Other | Left bundle branch pacing group |
Primary outcome
Detection of the position of the left bundle branch area on x-ray fluoroscopy
Time frame: 12 months
The accuracy of left bundle branch area detection will be measured as intersection-over-union (IoU) with the use of a convolutional neural network
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Bundle Branch Pacing and Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aldo Rinaldi, MD, MBBS, FRCP, FHRS (0207 188 9275, aldo.rinaldi@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of the position of the left bundle branch area on x-ray fluoroscopy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.