Observational study – patients undergoing physiological pacing (His Bundle) – analysing the electrical information obtained at the time of implant
| ISRCTN | ISRCTN14600175 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14600175 |
| Secondary identifying numbers | 41324 |
- Submission date
- 08/04/2019
- Registration date
- 08/04/2019
- Last edited
- 18/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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 April 2022
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, p.foley1@nhs.net
Contact information
Scientific
The Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
United Kingdom
| Phone | 01793 607460 |
|---|---|
| p.foley1@nhs.net |
Study information
| Study design | Non-randomised Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN14600175_PIS_v3.0_04Apr2019.pdf |
| Scientific title | High fidelity recording of His bundle electrograms for development of His specific algorithm |
| Study objectives | 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 signals. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | Arrhythmia |
| Intervention | 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. |
| Intervention type | Other |
| 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 study start date | 01/02/2019 |
| Completion date | 01/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Key inclusion criteria | 1. Patients undergoing His bundle pacing |
| Key exclusion criteria | 1. Failure to capture the His bundle 2. Unable to consent |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 01/04/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Swindon
SN3 6BB
United Kingdom
Sponsor information
Hospital/treatment centre
Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
England
United Kingdom
"ROR" |
https://ror.org/04g6v3637 |
|---|
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Depending on findings this may generate a publication or may just help develop pacemaker algorithms |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v3.0 | 04/04/2019 | 08/04/2019 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN14600175_PIS_v3.0_04Apr2019.pdf
- uploaded 08/04/2019
Editorial Notes
18/10/2021: The following changes were made to the trial record:
1. The recruitment resumed.
2. The overall end date was changed from 01/06/2021 to 01/04/2022.
3. The recruitment start date was changed from 01/12/2020 to 01/04/2022.
3. The plain English summary was updated to reflect these changes.
16/04/2020: Due to current public health guidance, recruitment for this study has been paused.
12/04/2019: Internal review.
