Atrial FibrillationNCT02016950
Long-term Pacemaker Arrhythmia Analysis
An observational study of Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Investigators seek to observe the long term patterns of arrhythmias detected by permanent pacemakers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 2,551 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Feb 2015
- 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: Those with permanent pacemakers
Who may be able to join
- Pre-existing dual chamber permanent pacemaker
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eastbourne General Hospital
Eastbourne, E Sussex, BN21 2UD
About this study
Official title: East Sussex Long-term Pacemaker Arrhythmia Analysis
Investigators seek to observe the long term patterns of arrhythmias detected by permanent pacemakers.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Permanent pacemaker | Pre-existing permanent pacemakers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation burden
Proportion of monitored time in atrial fibrillation
Measured: 28 days to 1 year
Secondary outcomes (1)
Atrial fibrillation episode frequency
Measured: 28 days to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,551 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Sulke, East Sussex Healthcare NHS Trust
- Investigators
- Neil Sulke, MD, Principal investigator, East Sussex Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016950
- Sponsor's protocol ID
- ESHT Pacemaker analysis
- Status last verified
- Feb 2015
- First submitted
- 11 Dec 2013
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sugihara C, Veasey R, Freemantle N, Podd S, Furniss S, Sulke N. The development of AF over time in patients with permanent pacemakers: objective assessment with pacemaker diagnostics demonstrates distinct patterns of AF. Europace. 2015 Jun;17(6):864-70. doi: 10.1093/europace/euv032.
PubMed 26023175
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- East Sussex Long-term Pacemaker Arrhythmia Analysis
- ClinicalTrials.gov ID
- NCT02016950
- Acronym / sponsor ID
- ESHT Pacemaker analysis
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,551 participants (actual)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Dec 2013 (estimated)
- 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.
Investigators seek to observe the long term patterns of arrhythmias detected by permanent pacemakers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Permanent pacemaker | – | –Pre-existing permanent pacemakers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those with permanent pacemakers
Key inclusion criteria (1 listed)
- Pre-existing dual chamber permanent pacemaker
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial fibrillation burden
Time frame: 28 days to 1 year
Proportion of monitored time in atrial fibrillation
1 secondary outcome
Atrial fibrillation episode frequency
Time frame: 28 days to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
- Derived from this study: PubMed 26023175Sugihara C, Veasey R, Freemantle N, Podd S, Furniss S, Sulke N. The development of AF over time in patients with permanent pacemakers: objective assessment with pacemaker diagnostics demonstrates distinct patterns of AF. Europace. 2015 Jun;17(6):864-70. doi: 10.1093/europace/euv032.
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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.
Neil Sulke, MD principal investigator
East Sussex Healthcare NHS Trust
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 Atrial Fibrillation, run by East Sussex Healthcare NHS 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Feb 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation burden (time frame: 28 days to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016950, which also lists 1 linked publication.
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 12 Feb 2015.