Plain English Summary
Background and study aims
Nowadays, pacemakers can work out how well the pacemaker is working, and make appropriate changes to the function automatically, so that it is rare that patients need to attend hospital to check how well the pacemaker is functioning.
In the last 5 to 10 years, we have begun to pace the normal electrical conducting system - which helps the heart function better than the older method. However, the electrical signals received by the pacemaker are very different and we need to try and characterise the signals so that the pacemakers can learn to recognise them on future generations of pacemakers.
We wish to help develop specific ways of programming pacemakers to cope with a new technique called His bundle pacing. Pacing the His bundle allows the pacemaker to use the natural conducting pathway activating the heart in a normal rapid fashion, avoiding some of the downsides of traditional right ventricular pacing such as development of heart failure. Current pacemakers do not have specific ways of understanding and managing His bundle pacing. This study involves taking the normal information obtained during the pacemaker implant, storing it and then analysing it later to develop ways of detecting and managing His bundle pacing.
Who can participate?
Patients who need a pacemaker
What does the study involve?
From the participants viewpoint, the implant is undertaken in the normal way. We wish to collect the data obtained during testing in a clear systematic way once alongside the usual x-ray images for later analysis. The procedure itself is the standard procedure.
What are the possible benefits and risks of participating?
The study does not involve additional risk. The benefit is for the future development of pacemakers. Occasionally additional unexpected abnormalities will be picked up during analysis of data which could benefit the patient.
Where is the study run from?
The Great Western Hospital, Swindon, UK
When is the study starting and how long is it expected to run for?
May 2019 to December 2020
Who is funding the study?
The study is supported by the National Institute for Health Research. The equipment to measure the signals is provided by Medtronic, a large medical device company. The signals will be analysed by scientists based at Aston University (Berthold Stegemann) in collaboration with the Bakken Research team from Medtronic.
Who is the main contact?
Dr Paul Foley, firstname.lastname@example.org
Dr Paul Foley
The Great Western Hospital
High fidelity recording of His bundle electrograms for development of His specific algorithm
Record the electrical signals during implant and during follow up of pacemakers undergoing His Bundle pacing for
standard clinical indications. The aim is to try and develop techniques to allow the pacemaker to automatically recognise His bundle pacing
Approved 11/03/2019, (Health Research Authority, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; 0207 104 8104; NRESCommittee.WestMidlands-Edgbaston@nhs.net), ref: 19/WM/0065
Non-randomised Cohort study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
We would like to approach a cohort of patients who are scheduled to undergo pacemaker implants for clinical indications. We would like to ask them to participate in this study.
Once the lead is implanted, during routine testing, we will analyse the recordings as per standard implant. We would like the participants to keep the recordings for later analysis. During follow up, we would like to keep the results of routine pacemaker function tests for analysis.
Primary outcome measure
His Bundle pacing associated electrocardiograms (EGMS) at implant and follow up.
Secondary outcome measures
To try and determine algorithms to recognise His Bundle pacing and differentiate from other cardiac stimulation during pacemaker stimulations.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Patients undergoing His bundle pacing
Target number of participants
Planned Sample Size: 40; UK Sample Size: 40
Participant exclusion criteria
1. Failure to capture the His bundle
2. Unable to consent
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Great Western Hospital
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
United States of America
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Depending on findings this may generate a publication or may just help develop pacemaker algorithms
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
All usual data will be stored using NHS password protected servers which are physically locked protected by security card access (audit trail) and CCTV. ECGs and fluoroscopic images for analysis will be exported and data anonymity will be preserved. All data will be held on password protected servers. The computers are password protected, and the hospital is accessed by security cards to open doors (audit trail). In addition, there is very high quality and high definition CCTV throughout the hospital.
Intention to publish date
Participant level data
Basic results (scientific)
- ISRCTN14600175_PIS_v3.0_04Apr2019.pdf uploaded 08/04/2019