Condition category
Circulatory System
Date applied
08/04/2019
Date assigned
08/04/2019
Last edited
12/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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, p.foley1@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Foley

ORCID ID

Contact details

The Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
United Kingdom
01793 607460
p.foley1@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41324

Study information

Scientific title

High fidelity recording of His bundle electrograms for development of His specific algorithm

Acronym

Study hypothesis

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

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

Study design

Non-randomised Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

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

01/02/2019

Overall trial end date

01/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients undergoing His bundle pacing

Participant type

Patient

Age group

Adult

Gender

Both

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

01/05/2019

Recruitment end date

01/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
United Kingdom

Sponsor information

Organisation

Great Western Hospitals NHS Foundation Trust

Sponsor details

Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Medtronic

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

01/06/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/04/2019: Internal review.