Atrial FibrillationNCT02442505
Device-detected Paroxysmal Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
This study will use an automated blood pressure monitor (Microlife WatchBP03) with an inbuilt algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with an implanted pacemaker who have previously documented paroxysmal (intermittent) atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Microlife WatchBP03 device
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Dec 2018
- 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: Patients who have an implanted pacemaker for sick sinus syndrome with previously documented AF with atrial high-rate episodes, with be identified from the pacemaker clinic register at one NHS Trust. Patients with AF and one of the following pacemakers will be identified from this register: Medtronic Sensia DR, Medtronic Advisa DR, Sorin Reply DR, and St. Jude Medical Accent DR and the study population will be randomly drawn from these patients. Atrial high rate episodes will be defined as atrial rates ≥180 beats per minute [3-6]. The exclusion criteria will include any patient who's pacemaker has had previously documented atrial sensing or pacing problem issues and patients with permanent AF.
Who may be able to join
- Patients with an implanted pacemaker for sick sinus syndrome with previously documented AF with atrial high-rate episodes
Who cannot join
- Any patient who's pacemaker has had previously documented atrial sensing or pacing problem issues
- Patients with permanent AF
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham, West Midlands, B18 7QH
About this study
Official title: Validation of the Modified Microlife Blood Pressure Monitor in Patients With Paroxysmal Atrial Fibrillation
This study will use an automated blood pressure monitor (Microlife WatchBP03) with an inbuilt algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with an implanted pacemaker who have previously documented paroxysmal (intermittent) atrial fibrillation. This study will compare the Microlife device detected atrial fibrillation episodes to the pacemaker detected atrial fibrillation episodes.
Read the detailed description
The modified Microlife blood pressure monitor is able to detect atrial fibrillation (AF) with high sensitivity (95%) and specificity (86%) and has a positive predictive value of 68% and negative predictive value of 98% for single readings. In addition, the modified device was also able to accurately classify the majority of the anomalous non-AF rhythms, although the specificity was highly variable, dependent upon the rhythm. However sinus rhythm was detected with a specificity of 97%. However, we do not currently know if the device would demonstrate a similar sensitivity in detecting AF in patients with paroxysmal AF.
Therefore, the present study will assess the sensitivity and specificity of the automated oscillometric device using a new AF algorithm among pacemaker patients with fast AF and atrial high-rate episodes and evaluate the effect of the specific rhythm abnormalities on the specificity for AF.
- Conditions
- Atrial Fibrillation
- Being tested
- Microlife WatchBP03 device
- Keywords
- Atrial Fibrillation; Pacemaker; Device-detected; Sensitivity; Specificity
- Medical subject headings
- Atrial Fibrillation, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microlife WatchBP03 deviceDevice
Microlife WatchBP03 device which is an automated oscillometric device using a new algorithm to detect atrial fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who are identified as having atrial fibrillation by both the pacemaker and the Microlife device (%)
True positive rate (sensitivity)
Measured: 24 hours
Percentage of patients who are identified as not having atrial fibrillation by both the pacemaker and the Microlife device (%)
True negative rate (specificity)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Sandwell & West Birmingham Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Gregory YH Lip, MD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442505
- Sponsor's protocol ID
- RG_13-114
- Status last verified
- May 2018
- First submitted
- 1 May 2015
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: IPD in an anonymised form can be made able upon direct request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Modified Microlife Blood Pressure Monitor in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02442505
- Acronym / sponsor ID
- RG_13-114
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation; Pacemaker; Device-detected; Sensitivity; Specificity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Sandwell & West Birmingham Hospitals NHS Trust
- Study start
- Oct 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 May 2015 (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.
This study will use an automated blood pressure monitor (Microlife WatchBP03) with an inbuilt algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with an implanted pacemaker who have previously documented paroxysmal (intermittent) atrial fibrillation. This study will compare the Microlife device detected atrial fibrillation episodes to the pacemaker detected atrial fibrillation episodes.
Detailed description
The modified Microlife blood pressure monitor is able to detect atrial fibrillation (AF) with high sensitivity (95%) and specificity (86%) and has a positive predictive value of 68% and negative predictive value of 98% for single readings. In addition, the modified device was also able to accurately classify the majority of the anomalous non-AF rhythms, although the specificity was highly variable, dependent upon the rhythm. However sinus rhythm was detected with a specificity of 97%. However, we do not currently know if the device would demonstrate a similar sensitivity in detecting AF in patients with paroxysmal AF.
Therefore, the present study will assess the sensitivity and specificity of the automated oscillometric device using a new AF algorithm among pacemaker patients with fast AF and atrial high-rate episodes and evaluate the effect of the specific rhythm abnormalities on the specificity for AF.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have an implanted pacemaker for sick sinus syndrome with previously documented AF with atrial high-rate episodes, with be identified from the pacemaker clinic register at one NHS Trust. Patients with AF and one of the following pacemakers will be identified from this register: Medtronic Sensia DR, Medtronic Advisa DR, Sorin Reply DR, and St. Jude Medical Accent DR and the study population will be randomly drawn from these patients. Atrial high rate episodes will be defined as atrial rates ≥180 beats per minute [3-6]. The exclusion criteria will include any patient who's pacemaker has had previously documented atrial sensing or pacing problem issues and patients with permanent AF.
Key inclusion criteria (1 listed)
- Patients with an implanted pacemaker for sick sinus syndrome with previously documented AF with atrial high-rate episodes
Key exclusion criteria (2 listed)
- Any patient who's pacemaker has had previously documented atrial sensing or pacing problem issues
- Patients with permanent AF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microlife WatchBP03 deviceMicrolife WatchBP03 device which is an automated oscillometric device using a new algorithm to detect atrial fibrillation | Device | – |
Primary outcome
Percentage of patients who are identified as having atrial fibrillation by both the pacemaker and the Microlife device (%)
Time frame: 24 hours
True positive rate (sensitivity)
Percentage of patients who are identified as not having atrial fibrillation by both the pacemaker and the Microlife device (%)
Time frame: 24 hours
True negative rate (specificity)
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 19 Apr 2019.
- Individual participant dataSharing planned: Undecided. IPD in an anonymised form can be made able upon direct request.
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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.
Gregory YH Lip, MD principal investigator
University of Birmingham
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 University of Birmingham 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 2 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 19 Apr 2019. 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?
Percentage of patients who are identified as having atrial fibrillation by both the pacemaker and the Microlife device (%) (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2019.