Paroxysmal Atrial FibrillationPhase 3NCT01917981
Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation
A Phase 3 study testing Personal Heart Rhythm Monitor in people with Paroxysmal Atrial Fibrillation and Stroke, run by University of Surrey at 2 sites in United Kingdom.
Trial summary
This study aims to determine the sensitivity and specificity of a Personal Heart Rhythm Monitor in the detection of prolonged paroxysmal atrial fibrillation (defined as lasting more than 12 hours) against pre-existing implantable devices, seen to be the 'gold-standard' for arrhythmia detection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Stroke
- What is being tested?
- Personal Heart Rhythm Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2013to Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prolonged AF (defined as an episode at least 12 hours duration) in the last month whilst attending routine pacemaker check
- Pacing requirement < 25% during the last month
Who cannot join
- Lack of capacity
- Inability to use the Personal Heart Rhythm Monitor due to cognitive or physical impairment
- Commencement of new anti-arrhythmic drug since last pacemaker check
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St Peter's Hospital
Chertsey, Surrey, KT16 0PJ
Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, GU2 7XX
About this study
Official title: Testing the Accuracy of an Intermittent Personal Heart Rhythm Monitor (PHRM) to Detect Prolonged Paroxysmal Atrial Fibrillation (PAF) Against Implantable Devices.
This study aims to determine the sensitivity and specificity of a Personal Heart Rhythm Monitor in the detection of prolonged paroxysmal atrial fibrillation (defined as lasting more than 12 hours) against pre-existing implantable devices, seen to be the 'gold-standard' for arrhythmia detection.
Read the detailed description
The Investigators aim to recruit 30 volunteers with implantable devices (either conventional pacemakers, with an atrial lead or implantable loop recorders, devices inserted under the skin to monitor the heart rhythm). They will be attending for their routine pacemaker checks in a number of clinics in Surrey.
Potential participants will have documented prolonged paroxysmal atrial fibrillation (PAF, an intermittent irregular heart rhythm which is known to predispose to stroke), lasting at least 12 hours, identified in the last month prior to the pacemaker check.
Willing patients will then be issued with a PHRM (Personal Heart Rhythm Monitor) device to make heart rhythm recordings for 3 months. They will do this twice-daily for 30 seconds for this period. At the end of the 3 month period patients will undergo a final pacing device check. Identification of prolonged PAF using the PHRM device will be compared to the implantable device.
- Conditions
- Paroxysmal Atrial Fibrillation, Stroke
- Being tested
- Personal Heart Rhythm Monitor
- Keywords
- Intermittent cardiac monitoring, Implantable device
- 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.
Personal Heart Rhythm MonitorDevice
Also called Portable ECG monitor HCG-801 - OMRON Healthcare
| Study group | Role | What they receive |
|---|---|---|
| Personal Heart Rhythm Monitor | Experimental | Intermittent cardiac monitoring with a Personal Heart Rhythm Monitor for three months. Receives: Device: Personal Heart Rhythm Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of detection of prolonged paroxysmal atrial fibrillation (PAF) using a Personal Heart Rhythm Monitor (PHRM), compared to an implantable device.
Measured (%) as the number of identified episodes of prolonged PAF using the PHRM compared to the gold standard implantable device in all patients over the 3 month period.
Measured: 18 months
Secondary outcomes (3)
The sensitivity and specificity of detection of all episodes of PAF using a PHRM, compared to an implantable device.
Measured (%) as the number of identified episodes of all episodes of PAF (lasting at least 30 seconds) using the PHRM compared to the gold standard implantable device in all patients over the 3 month period.
Measured: 18 months
Participant compliance with twice-daily recordings with the PHRM for a three month period.
Measured as actual number of recordings made out of 180 requested recordings and expressed as a percentage.
Measured: 18 months
The concordance of the interpretation of PHRM recordings by a Research Nurse and blinded Cardiologist.
The agreement in the diagnosis of normal sinus rhythm and PAF using PHRM recordings between a Research Nurse and Cardiologist expressed as a percentage.
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 posted7 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Failure to recruit.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Surrey County Hospital NHS Foundation Trust, Ashford and St. Peter's Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Philippa J Howlett, MBChB MRCP, Principal investigator, The University of Surrey and The Royal Surrey County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917981
- Sponsor's protocol ID
- HASTE-1
- Status last verified
- Apr 2017
- First submitted
- 12 Jul 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
- Testing the Accuracy of an Intermittent Personal Heart Rhythm Monitor (PHRM) to Detect Prolonged Paroxysmal Atrial Fibrillation (PAF) Against Implantable Devices.
- ClinicalTrials.gov ID
- NCT01917981
- Acronym / sponsor ID
- HASTE-1
- Conditions
- Paroxysmal Atrial Fibrillation, Stroke
- Keywords
- Intermittent cardiac monitoring, Implantable device
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failure to recruit.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Royal Surrey County Hospital NHS Foundation Trust, Ashford and St. Peter's Hospitals NHS Trust
- Study start
- Sep 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Aug 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 study aims to determine the sensitivity and specificity of a Personal Heart Rhythm Monitor in the detection of prolonged paroxysmal atrial fibrillation (defined as lasting more than 12 hours) against pre-existing implantable devices, seen to be the 'gold-standard' for arrhythmia detection.
Detailed description
The Investigators aim to recruit 30 volunteers with implantable devices (either conventional pacemakers, with an atrial lead or implantable loop recorders, devices inserted under the skin to monitor the heart rhythm). They will be attending for their routine pacemaker checks in a number of clinics in Surrey.
Potential participants will have documented prolonged paroxysmal atrial fibrillation (PAF, an intermittent irregular heart rhythm which is known to predispose to stroke), lasting at least 12 hours, identified in the last month prior to the pacemaker check.
Willing patients will then be issued with a PHRM (Personal Heart Rhythm Monitor) device to make heart rhythm recordings for 3 months. They will do this twice-daily for 30 seconds for this period. At the end of the 3 month period patients will undergo a final pacing device check. Identification of prolonged PAF using the PHRM device will be compared to the implantable device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personal Heart Rhythm Monitor | Experimental | Device: Personal Heart Rhythm MonitorIntermittent cardiac monitoring with a Personal Heart Rhythm Monitor for three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prolonged AF (defined as an episode at least 12 hours duration) in the last month whilst attending routine pacemaker check
- Pacing requirement < 25% during the last month
Key exclusion criteria (3 listed)
- Lack of capacity
- Inability to use the Personal Heart Rhythm Monitor due to cognitive or physical impairment
- Commencement of new anti-arrhythmic drug since last pacemaker check
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 |
|---|---|---|
| Personal Heart Rhythm MonitorAlso: Portable ECG monitor HCG-801 - OMRON Healthcare | Device | Personal Heart Rhythm Monitor |
Primary outcome
The sensitivity and specificity of detection of prolonged paroxysmal atrial fibrillation (PAF) using a Personal Heart Rhythm Monitor (PHRM), compared to an implantable device.
Time frame: 18 months
Measured (%) as the number of identified episodes of prolonged PAF using the PHRM compared to the gold standard implantable device in all patients over the 3 month period.
3 secondary outcomes
The sensitivity and specificity of detection of all episodes of PAF using a PHRM, compared to an implantable device.
Time frame: 18 months
Participant compliance with twice-daily recordings with the PHRM for a three month period.
Time frame: 18 months
The concordance of the interpretation of PHRM recordings by a Research Nurse and blinded Cardiologist.
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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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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 J Howlett, MBChB MRCP principal investigator
The University of Surrey and The Royal Surrey County Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Personal Heart Rhythm Monitor in people with Paroxysmal Atrial Fibrillation and Stroke, run by University of Surrey at 2 sites 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 2 inclusion and 3 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: withdrawn, 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 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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 sensitivity and specificity of detection of prolonged paroxysmal atrial fibrillation (PAF) using a Personal Heart Rhythm Monitor (PHRM), compared to an implantable device. (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.