PresyncopeIPEDNCT02783898
The IPED (Investigation of Palpitations in the ED) Study
A study testing AliveCor Heart Monitor in people with Presyncope and Arrhythmias, Cardiac, run by NHS Lothian at 10 sites in United Kingdom.
Trial summary
Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near blackout) are common ED problems sometimes due to an abnormal cardiac rhythm. This is difficult to diagnose as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Presyncope, Arrhythmias, Cardiac, Tachycardia, Supraventricular
- What is being tested?
- AliveCor Heart Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Jun 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant aged 16 years or over
- Participant presenting with an episode of palpitations or pre-syncope
- Participant's underlying ECG rhythm during these episodes remains undiagnosed after clinical assessment.
Who cannot join
- Prior diagnostic ECG
- Palpitations or pre-syncope present during an admission ECG
- Frequent episodes (i.e. at least once a day)
- Participants under 16 years of age
- Previous participation in the study
- Inability or unwilling to give informed consent.
Show all 12Show fewer
- Participants with recent (i.e. within 3 months) myocardial infarction, severe heart failure (NYHA class 4) or unstable angina
- Participants unwilling or unable to use the AliveCor Heart Monitor and AliveECG app
- Participants without a compatible smart phone or tablet
- Participants with cardiac pacemakers or other implanted electronic devices
- No telephone number for follow-up
- Participant in custody
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Chesterfield
Chesterfield
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA
Royal Devon and Exeter Hospital
Exeter
Leicester Royal Infirmary
Leicester, LE1 5WW
Royal London Hospital, Barts NHS Trust
London
Whipps Cross Hospital, Barts NHS Trust
London
Nottingham University Hospital
Nottingham, NG7 2UH
Derriford Hospital
Plymouth
Royal Berkshire Hospital
Reading
Musgrove Park Hospital
Taunton
About this study
Official title: Randomised Controlled Trial of the Use of a Smart Phone Based Event Recorder Versus Standard Care for Patients Presenting to the Emergency Department With Palpitations and Pre-syncope
Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near blackout) are common ED problems sometimes due to an abnormal cardiac rhythm. This is difficult to diagnose as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients are usually discharged with advice to return to the ED again for a 12-lead ECG should symptoms recur. The investigators will recruit 242 adult participants to either study or control arms. All study arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. Control arm participants will receive standard care only. Both groups will be followed-up at 90 days. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients with a compatible smart phone or tablet, and revolutionise ED care in this area.
Read the detailed description
Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre syncope (near blackout) are common ED problems sometimes due to an abnormal heart rhythm. Diagnosis is difficult as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients are usually advised to return to the ED for a 12-lead ECG should symptoms recur. The investigators will recruit 242 participants aged 16 years or over presenting to the ED or Medical Assessment Unit of the Royal Infirmary of Edinburgh with an episode of palpitations or pre-syncope and who remain undiagnosed after ED assessment. The investigators will randomise and allocate participants to either study or control arms. All study arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. Control arm participants will receive standard care only. If a participant allocated to the study arm has palpitations or pre-syncope during the 90-day study period, the participant can record an ECG using the AliveCor Monitor which can be viewed by the study team. Participants will be asked to log symptoms and whether the participant was able to record an ECG during the symptoms in a participant symptom diary, which the participant will return to the research team along with the Participant satisfaction and compliance questionnaire, and smart phone based event recorder at the end of the 90 days in a pre-paid stamped, addressed envelope. Participants will be phoned at 90 days to remind the participant to complete the Participant satisfaction and compliance questionnaire and to return this with the symptom diary and smart phone based event recorder. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients.
- Being tested
- AliveCor Heart Monitor
- Keywords
- pre syncope, palpitations
- Medical subject headings
- Syncope, Arrhythmias, Cardiac, Tachycardia, Supraventricular, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliveCor Heart MonitorDevice
Smart phone based ECG event recorder
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service. Receives: Device: AliveCor Heart Monitor |
| Control | No intervention | All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Symptomatic Rhythm Detection up to 90 Days
Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.
Measured: 90 days
Secondary outcomes (8)
Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days
Symptomatic rhythm detection rate of a smart phone based event recorder for cardiac arrhythmia detection versus standard care
Measured: 90 days
Time to Detection of Symptomatic Rhythm
Time to detection of symptomatic rhythm using a smart phone based event recorder versus standard care
Measured: 90 days
Time to Detection of Cardiac Arrhythmia Rhythm
Time to detection of cardiac arrhythmia rhythm using a smart phone based event recorder versus standard care
Measured: 90 days
Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia
Number of participants treated or (planned for treatment) for cardiac arrhythmia in participants using a smart phone based event recorder versus standard care
Measured: 90 days
Number of Participants Finding the AliveCor Heart Monitor Easy to Use
Number of Participants answering the participant questionnaire and finding the AliveCor heart monitor easy to use
Measured: 90 days
Financial Cost Per Diagnosis of Symptomatic Rhythm
Financial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care.
Measured: 90 days
Number of Participants With Serious Outcome up to 90 Days
Number of patients with all cause death and/or major adverse cardiac events (MACE; myocardial infarction, life threatening arrhythmia, insertion of pacemaker or internal cardiac defibrillator, insertion of pacing wire).
Measured: 90 days
Number of Participants Completing Questionnaire
Measure of questionnaire compliance - Number of participants completing questionnaire
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PresyncopeStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Matthew J Reed, MA FRCEM MD, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783898
- Sponsor's protocol ID
- 2016/0153
- Other IDs
- R15/A164, PG/17/63/33198
- Acronym
- IPED
- Status last verified
- Mar 2018
- First submitted
- 23 Mar 2016
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thiruganasambandamoorthy V, Taljaard M, Stiell IG, Sivilotti ML, Murray H, Vaidyanathan A, Rowe BH, Calder LA, Lang E, McRae A, Sheldon R, Wells GA. Emergency department management of syncope: need for standardization and improved risk stratification. Intern Emerg Med. 2015 Aug;10(5):619-27. doi: 10.1007/s11739-015-1237-1. Epub 2015 Apr 28.
PubMed 25918108Probst MA, Mower WR, Kanzaria HK, Hoffman JR, Buch EF, Sun BC. Analysis of emergency department visits for palpitations (from the National Hospital Ambulatory Medical Care Survey). Am J Cardiol. 2014 May 15;113(10):1685-90. doi: 10.1016/j.amjcard.2014.02.020. Epub 2014 Mar 1.
PubMed 24698469Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, Albert DE, Freedman SB. iPhone ECG application for community screening to detect silent atrial fibrillation: a novel technology to prevent stroke. Int J Cardiol. 2013 Apr 30;165(1):193-4. doi: 10.1016/j.ijcard.2013.01.220. Epub 2013 Mar 7. No abstract available.
PubMed 23465249Lowres N, Neubeck L, Salkeld G, Krass I, McLachlan AJ, Redfern J, Bennett AA, Briffa T, Bauman A, Martinez C, Wallenhorst C, Lau JK, Brieger DB, Sy RW, Freedman SB. Feasibility and cost-effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies. The SEARCH-AF study. Thromb Haemost. 2014 Jun;111(6):1167-76. doi: 10.1160/TH14-03-0231. Epub 2014 Apr 1.
PubMed 24687081Haberman ZC, Jahn RT, Bose R, Tun H, Shinbane JS, Doshi RN, Chang PM, Saxon LA. Wireless Smartphone ECG Enables Large-Scale Screening in Diverse Populations. J Cardiovasc Electrophysiol. 2015 May;26(5):520-6. doi: 10.1111/jce.12634. Epub 2015 Mar 19.
PubMed 25651872Tarakji KG, Wazni OM, Callahan T, Kanj M, Hakim AH, Wolski K, Wilkoff BL, Saliba W, Lindsay BD. Using a novel wireless system for monitoring patients after the atrial fibrillation ablation procedure: the iTransmit study. Heart Rhythm. 2015 Mar;12(3):554-559. doi: 10.1016/j.hrthm.2014.11.015. Epub 2014 Nov 18.
PubMed 25460854Reed MJ, Grubb NR, Lang CC, O'Brien R, Simpson K, Padarenga M, Grant A, Tuck S, Keating L, Coffey F, Jones L, Harris T, Lloyd G, Gagg J, Smith JE, Coats T. Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study. EClinicalMedicine. 2019 Mar 3;8:37-46. doi: 10.1016/j.eclinm.2019.02.005. eCollection 2019 Feb.
PubMed 31193636Reed MJ, Grubb NR, Lang CC, O'Brien R, Simpson K, Padarenga M, Grant A, Tuck S. Multi-centre randomised controlled trial of a smart phone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope - the IPED (Investigation of Palpitations in the ED) study: study protocol for a randomised controlled trial. Trials. 2018 Dec 29;19(1):711. doi: 10.1186/s13063-018-3098-1.
PubMed 30594256
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of the Use of a Smart Phone Based Event Recorder Versus Standard Care for Patients Presenting to the Emergency Department With Palpitations and Pre-syncope
- ClinicalTrials.gov ID
- NCT02783898
- Acronym / sponsor ID
- IPED / 2016/0153
- Keywords
- pre syncope, palpitations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- Jun 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Posted 1 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near blackout) are common ED problems sometimes due to an abnormal cardiac rhythm. This is difficult to diagnose as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients are usually discharged with advice to return to the ED again for a 12-lead ECG should symptoms recur. The investigators will recruit 242 adult participants to either study or control arms. All study arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. Control arm participants will receive standard care only. Both groups will be followed-up at 90 days. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients with a compatible smart phone or tablet, and revolutionise ED care in this area.
Detailed description
Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre syncope (near blackout) are common ED problems sometimes due to an abnormal heart rhythm. Diagnosis is difficult as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients are usually advised to return to the ED for a 12-lead ECG should symptoms recur. The investigators will recruit 242 participants aged 16 years or over presenting to the ED or Medical Assessment Unit of the Royal Infirmary of Edinburgh with an episode of palpitations or pre-syncope and who remain undiagnosed after ED assessment. The investigators will randomise and allocate participants to either study or control arms. All study arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. Control arm participants will receive standard care only. If a participant allocated to the study arm has palpitations or pre-syncope during the 90-day study period, the participant can record an ECG using the AliveCor Monitor which can be viewed by the study team. Participants will be asked to log symptoms and whether the participant was able to record an ECG during the symptoms in a participant symptom diary, which the participant will return to the research team along with the Participant satisfaction and compliance questionnaire, and smart phone based event recorder at the end of the 90 days in a pre-paid stamped, addressed envelope. Participants will be phoned at 90 days to remind the participant to complete the Participant satisfaction and compliance questionnaire and to return this with the symptom diary and smart phone based event recorder. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Device: AliveCor Heart MonitorAll STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service. |
| Control | No intervention | –All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participant aged 16 years or over
- Participant presenting with an episode of palpitations or pre-syncope
- Participant's underlying ECG rhythm during these episodes remains undiagnosed after clinical assessment.
Key exclusion criteria (12 listed)
- Prior diagnostic ECG
- Palpitations or pre-syncope present during an admission ECG
- Frequent episodes (i.e. at least once a day)
- Participants under 16 years of age
- Previous participation in the study
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 |
|---|---|---|
| AliveCor Heart MonitorSmart phone based ECG event recorder | Device | Study |
Primary outcome
Number of Participants With Symptomatic Rhythm Detection up to 90 Days
Time frame: 90 days
Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.
8 secondary outcomes
Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days
Time frame: 90 days
Time to Detection of Symptomatic Rhythm
Time frame: 90 days
Time to Detection of Cardiac Arrhythmia Rhythm
Time frame: 90 days
Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia
Time frame: 90 days
Number of Participants Finding the AliveCor Heart Monitor Easy to Use
Time frame: 90 days
Financial Cost Per Diagnosis of Symptomatic Rhythm
Time frame: 90 days
Number of Participants With Serious Outcome up to 90 Days
Time frame: 90 days
Number of Participants Completing Questionnaire
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25918108Thiruganasambandamoorthy V, Taljaard M, Stiell IG, Sivilotti ML, Murray H, Vaidyanathan A, Rowe BH, Calder LA, Lang E, McRae A, Sheldon R, Wells GA. Emergency department management of syncope: need for standardization and improved risk stratification. Intern Emerg Med. 2015 Aug;10(5):619-27. doi: 10.1007/s11739-015-1237-1. Epub 2015 Apr 28.
- Background: PubMed 24698469Probst MA, Mower WR, Kanzaria HK, Hoffman JR, Buch EF, Sun BC. Analysis of emergency department visits for palpitations (from the National Hospital Ambulatory Medical Care Survey). Am J Cardiol. 2014 May 15;113(10):1685-90. doi: 10.1016/j.amjcard.2014.02.020. Epub 2014 Mar 1.
- Background: PubMed 23465249Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, Albert DE, Freedman SB. iPhone ECG application for community screening to detect silent atrial fibrillation: a novel technology to prevent stroke. Int J Cardiol. 2013 Apr 30;165(1):193-4. doi: 10.1016/j.ijcard.2013.01.220. Epub 2013 Mar 7. No abstract available.
- Background: PubMed 24687081Lowres N, Neubeck L, Salkeld G, Krass I, McLachlan AJ, Redfern J, Bennett AA, Briffa T, Bauman A, Martinez C, Wallenhorst C, Lau JK, Brieger DB, Sy RW, Freedman SB. Feasibility and cost-effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies. The SEARCH-AF study. Thromb Haemost. 2014 Jun;111(6):1167-76. doi: 10.1160/TH14-03-0231. Epub 2014 Apr 1.
- Background: PubMed 25651872Haberman ZC, Jahn RT, Bose R, Tun H, Shinbane JS, Doshi RN, Chang PM, Saxon LA. Wireless Smartphone ECG Enables Large-Scale Screening in Diverse Populations. J Cardiovasc Electrophysiol. 2015 May;26(5):520-6. doi: 10.1111/jce.12634. Epub 2015 Mar 19.
- Background: PubMed 25460854Tarakji KG, Wazni OM, Callahan T, Kanj M, Hakim AH, Wolski K, Wilkoff BL, Saliba W, Lindsay BD. Using a novel wireless system for monitoring patients after the atrial fibrillation ablation procedure: the iTransmit study. Heart Rhythm. 2015 Mar;12(3):554-559. doi: 10.1016/j.hrthm.2014.11.015. Epub 2014 Nov 18.
- Derived from this study: PubMed 31193636Reed MJ, Grubb NR, Lang CC, O'Brien R, Simpson K, Padarenga M, Grant A, Tuck S, Keating L, Coffey F, Jones L, Harris T, Lloyd G, Gagg J, Smith JE, Coats T. Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study. EClinicalMedicine. 2019 Mar 3;8:37-46. doi: 10.1016/j.eclinm.2019.02.005. eCollection 2019 Feb.
- Derived from this study: PubMed 30594256Reed MJ, Grubb NR, Lang CC, O'Brien R, Simpson K, Padarenga M, Grant A, Tuck S. Multi-centre randomised controlled trial of a smart phone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope - the IPED (Investigation of Palpitations in the ED) study: study protocol for a randomised controlled trial. Trials. 2018 Dec 29;19(1):711. doi: 10.1186/s13063-018-3098-1.
- Individual participant dataSharing planned: No
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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.
Matthew J Reed, MA FRCEM MD principal investigator
NHS Lothian
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AliveCor Heart Monitor in people with Presyncope and Arrhythmias, Cardiac, run by NHS Lothian at 10 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 3 inclusion and 12 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 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Symptomatic Rhythm Detection up to 90 Days (time frame: 90 days). 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 NCT02783898, which also lists 8 linked publications.
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 Nov 2019.