Plain English Summary
Background and study aims
Atrial fibrillation (AF) is a heart rhythm disorder that affects up to 2% of the population and is associated with stroke, heart failure and death. The disease is caused by a disturbance in the electrical activity within the heart. Over the past 18 years treatment for AF has expanded dramatically, following crucial observations about the areas in one of the upper chambers of the heart (the left atrium) where the heat rhythm disturbance begins. While the origin of AF is now much better understood, the processes by which the abnormal rhythm continues remains less well understood. This has limited the development of more successful treatments for AF and at present, those patients with the ‘persistent' form of the condition have a significantly lower success rate when they are treated than those with the earlier, stop-start from of the condition (paroxysmal AF). The aim of this study is to take electrical measurements from within the chambers of the heart affected in this, and related, heart rhythm disorders in order to better understand the processes that allow them to persist. In the future it is hoped that this will result in more effective treatment for these conditions.
Who can participate?
Adults who are undergoing surgery to treat a heart rhythm disorder (such as AF) as part of their normal care.
What does the study involve?
After enrolment in the study, all participants undergo an RFA procedure as part of their standard care. This is a commonly used treatment for AF, which involves a thin flexible tube (catheter) being inserted through a major artery and guided up to the heart, where it burns the damaged area of the heart away using radiation. At the time of the RFA procedure a series of additional electrical measurements (extending the procedure by no more than 30 minutes) are taken. At the end of their RFA procedure the participants involvement with the study is complete.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating, although it is hoped that the knowledge gained from taking these measurements will be directly relevant to patients with heart rhythm disorders in the future.
Where is the study run from?
St Thomas' Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2015 to October 2019
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Dr John Whitaker
john.whitaker@kcl.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EPStim
Study information
Scientific title
Programmed cardiac stimulation to measure electrophysiological function
Acronym
EP Stim
Study hypothesis
The aim of this study is to develop and refine protocols for the invasive assessment of cardiac electrophysiological properties.
Ethics approval
South East Coast - Surrey Research Ethics Committee, 30/11/2015, ref: 15/LO/1889
Study design
Observational cross sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format,please use contact details to request participant information sheet
Condition
Heart rhythm disorders
Intervention
At the time of clinically indicated electrophysiology study a series of additional electrical measurements will be made using clinically approved equipment and restricted to the cardiac chambers to which access is required for the clinical procedure.
Intervention type
Phase
Drug names
Primary outcome measure
Cardiac conductivity and refractoriness will be assessed using analysis of recorded electrograms recorded at the time of the clinically indicated electrophysiology study.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/10/2015
Overall trial end date
01/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Between the ages of 18 and 85
2. Capable of giving informed, written consent in English
3. Undergoing a clinically indicated electrophysiology study or atrial fibrillation ablation procedure
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patient is not able or willing to provide written, informed consent in English
2. Patient does not meet all of the inclusion criteria
3. Patient is enrolled in another clinical trial that involves an extension of the duration of the EP study or AF ablation procedure
4. Patient is a female and of childbearing potential
Recruitment start date
26/01/2016
Recruitment end date
01/10/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas' Hospital
Guy's and St Thomas' NHS Foundation Trust
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust
Sponsor details
Research & Development Department
16th Floor
Tower Wing
Great Maze pond
London
SE1 9RT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Organisation
King's College London
Sponsor details
Director of Research Management
Director of Administration (Health Schools)
Room 1.8 Hodgkin Building
Guy's Campus
King's College London
London
SE1 4UL
United Kingdom
Sponsor type
University/education
Website
Organisation
Guy's and St Thomas' NHS Foundation Trust
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication of study results in a high impact peer reviewed journal when he data collection and analysis are complete.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/10/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list