Paroxysmal Atrial FibrillationPhase 3NCT01867060
Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community
A Phase 3 study testing Automated Cardiac Event Recorder and Personal Heart Rhythm Monitor in people with Paroxysmal Atrial Fibrillation and Stroke, run by University of Surrey at 1 site in United Kingdom.
Trial summary
This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Stroke
- What is being tested?
- Automated Cardiac Event Recorder and Personal Heart Rhythm Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to Aug 2016
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Suspected paroxysmal AF (either palpitations consistent with AF or an irregular pulse)
- 12-lead resting ECG confirming sinus rhythm
- Capacity to consent to study
- English-speaking
- Life expectancy at least one year
Who cannot join
- Previous diagnosis of AF
- Recent history of syncope
- Recent history of cardiac-sounding chest pain
- A resting ECG suggestive of alternative arrhythmia
- Inability to use the telephone
- Thyrotoxicosis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, GU2 7XX
About this study
Official title: Using a Personal Heart Rhythm Monitor (PHRM) to Diagnose Paroxsymal Atrial Fibrillation (PAF) in the Community; and the PREDICT-PAF Substudy - an Investigation of Biomarkers to Detect PAF.
This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week.
A case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.
Read more
A further case-control study will assess markers of left atrial function in patients with PAF and their matched controls.
Another case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.
Read the detailed description
Patients with suspected AF will be initially referred to a community-based, nurse-led Arrhythmia clinic by their General Practitioners over a 15-month period.
All patients will be issued with a one week ACER (the 'R. Test 4 Evolution'), seen as the 'best-practice' investigation for this population group. Participants will also be issued with a PHRM for three months. They will be instructed to take regular twice-daily, 30 second recordings with additional recordings in the event of relevant symptoms. They will return the ACER after one week and the PHRM after 3 months.
A subgroup of participants (target recruitment number = 100) will undergo transthoracic echocardiography. A 40ml venous blood sample will also be taken. Another small subgroup (target recruitment = 20) will be asked to continue twice-daily recordings using the PHRM for a further nine months and will be issued with a repeat one week ACER at study completion.
- Conditions
- Paroxysmal Atrial Fibrillation, Stroke
- Being tested
- Automated Cardiac Event Recorder, Personal Heart Rhythm Monitor
- Keywords
- Cardiac monitoring, Biomarkers, Transthoracic echocardiography
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Cardiac Event RecorderDevice
Also called 'R. Test Evolution 4' (Novacor).
Automated Cardiac Event Recorder to be worn continuously for one week.
Personal Heart Rhythm MonitorDevice
Also called 'Portable ECG monitor HCG-801' (OMRON Healthcare).
Personal Heart Rhythm Monitor to be used twice-daily for three months.
| Study group | Role | What they receive |
|---|---|---|
| Personal Heart Rhythm Monitor | Other | Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor. Receives: Device: Automated Cardiac Event Recorder; Device: Personal Heart Rhythm Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect all episodes of paroxysmal atrial fibrillation.
Measured: 18 months
Secondary outcomes (8)
The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect prolonged episodes of paroxysmal atrial fibrillation (defined as greater than 12 hours).
Measured: 18 months
The sensitivity and specificity of serum biomarkers to detect cases of PAF.
Measured: 18 months
The sensitivity and specificity of markers of left atrial function to predict PAF.
Measured: 18 months
The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.
Measured: 18 months
Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.
Measured: 30 months
Stroke reduction in the local area
A reduction in stroke burden in the local area will be calculated from estimated stroke risk in individuals identified with AF and from a local registry.
Measured: 30 months
Referrals to secondary care for suspected AF/palpitations
The number of referrals to secondary care for suspected PAF will be analysed.
Measured: 18 months
Participant satisfaction with the devices used in the study.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Surrey County Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Philippa Howlett, MBChB BSc, Principal investigator, The Royal Surrey County HospitalEdward Leatham, MBChB MD, Study director, The Royal Surrey County HospitalChris Fry, BSc PhD, Study director, The University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867060
- Sponsor's protocol ID
- HASTE-2
- Status last verified
- Apr 2017
- First submitted
- 29 May 2013
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Personal Heart Rhythm Monitor (PHRM) to Diagnose Paroxsymal Atrial Fibrillation (PAF) in the Community; and the PREDICT-PAF Substudy - an Investigation of Biomarkers to Detect PAF.
- ClinicalTrials.gov ID
- NCT01867060
- Acronym / sponsor ID
- HASTE-2
- Conditions
- Paroxysmal Atrial Fibrillation, Stroke
- Keywords
- Cardiac monitoring, Biomarkers, Transthoracic echocardiography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Royal Surrey County Hospital NHS Foundation Trust
- Study start
- May 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Jun 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.
This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week.
A case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.
A further case-control study will assess markers of left atrial function in patients with PAF and their matched controls.
Another case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.
Detailed description
Patients with suspected AF will be initially referred to a community-based, nurse-led Arrhythmia clinic by their General Practitioners over a 15-month period.
All patients will be issued with a one week ACER (the 'R. Test 4 Evolution'), seen as the 'best-practice' investigation for this population group. Participants will also be issued with a PHRM for three months. They will be instructed to take regular twice-daily, 30 second recordings with additional recordings in the event of relevant symptoms. They will return the ACER after one week and the PHRM after 3 months.
A subgroup of participants (target recruitment number = 100) will undergo transthoracic echocardiography. A 40ml venous blood sample will also be taken. Another small subgroup (target recruitment = 20) will be asked to continue twice-daily recordings using the PHRM for a further nine months and will be issued with a repeat one week ACER at study completion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personal Heart Rhythm Monitor | Other | Device: Automated Cardiac Event Recorder, Device: Personal Heart Rhythm MonitorAutomated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Suspected paroxysmal AF (either palpitations consistent with AF or an irregular pulse)
- 12-lead resting ECG confirming sinus rhythm
- Capacity to consent to study
- English-speaking
- Life expectancy at least one year
Key exclusion criteria (6 listed)
- Previous diagnosis of AF
- Recent history of syncope
- Recent history of cardiac-sounding chest pain
- A resting ECG suggestive of alternative arrhythmia
- Inability to use the telephone
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 |
|---|---|---|
| Automated Cardiac Event RecorderAlso: 'R. Test Evolution 4' (Novacor).Automated Cardiac Event Recorder to be worn continuously for one week. | Device | Personal Heart Rhythm Monitor |
| Personal Heart Rhythm MonitorAlso: 'Portable ECG monitor HCG-801' (OMRON Healthcare).Personal Heart Rhythm Monitor to be used twice-daily for three months. | Device | Personal Heart Rhythm Monitor |
Primary outcome
The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect all episodes of paroxysmal atrial fibrillation.
Time frame: 18 months
8 secondary outcomes
The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect prolonged episodes of paroxysmal atrial fibrillation (defined as greater than 12 hours).
Time frame: 18 months
The sensitivity and specificity of serum biomarkers to detect cases of PAF.
Time frame: 18 months
The sensitivity and specificity of markers of left atrial function to predict PAF.
Time frame: 18 months
The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.
Time frame: 18 months
Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.
Time frame: 30 months
Stroke reduction in the local area
Time frame: 30 months
Referrals to secondary care for suspected AF/palpitations
Time frame: 18 months
Participant satisfaction with the devices used in the study.
Time frame: 18 months
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 26 Apr 2017.
- HASTE charity websiteLink provided by the sponsor.
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A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
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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.
Philippa Howlett, MBChB BSc principal investigator
The Royal Surrey County Hospital
Edward Leatham, MBChB MD study director
The Royal Surrey County Hospital
Chris Fry, BSc PhD study director
The University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Automated Cardiac Event Recorder and Personal Heart Rhythm Monitor in people with Paroxysmal Atrial Fibrillation and Stroke, run by University of Surrey 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 5 inclusion and 6 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 26 Apr 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect all episodes of paroxysmal atrial fibrillation. (time frame: 18 months). 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 26 Apr 2017.