PalpitationsLIAISENCT01170559
Use of Loop Recorders for Diagnosis of Palpitations in A&E
A study testing Implantable Loop Recorder in people with Palpitations, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Heart rhythm abnormalities underlie one of the common presenting complaints to the A\&E and out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having symptoms, it is very difficult to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palpitations
- What is being tested?
- Implantable Loop Recorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Aug 2016
- Phase
- Interventional
- 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
- Age 18 years or older
- Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness)
- Terminates before presentation to hospital
- Episodes occur at a frequency of less than once every two weeks
- Never previously caught on ECG or ambulatory monitoring
- Normal resting ECG
Who cannot join
- Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR >1.6, ongoing infection, sepsis or fever, etc.
- Palpitations suggestive of extrasystoles (single missed or dropped beats)
- Known or suspected severe valvular or myocardial heart disease
- An audible heart murmur
- Any abnormality on the surface ECG
- Thyrotoxicosis
- Patients who refuse an ILR when offered will not be included in either limb of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Implantable Loop Recorders as a Primary Investigation of Infrequent Undiagnosed ArrhythmIa Symptoms in the Emergency Department
Heart rhythm abnormalities underlie one of the common presenting complaints to the A\&E and out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having symptoms, it is very difficult to determine the cause of the palpitations. The conventional approach is to refer these patients from the emergency departments to the Cardiology outpatients where they undergo repeated short term rhythm monitoring hoping to record the rhythm underlying the patient's complaint. Unfortunately, this often yields no results thus delaying definitive treatment and incurring extra costs of repeated investigations and A\&E presentations. This study aims to compare the ability of the conventional approach to establish a definite diagnosis compared to that of an early invasive monitoring approach with a small implantable device that records the heart rhythm at all time for up to 18 months.
- Conditions
- Palpitations
- Being tested
- Implantable Loop Recorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Loop RecorderDevice
Also called Reveal XT
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ILR Group | Experimental | Group allocated to receiving an ILR in the A\&E department. Receives: Device: Implantable Loop Recorder |
| Group 2: Conventional | No intervention | Group randomised to conventional lines of investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is the proportion of patients achieving a definite diagnosis in each of the two groups at the end of one year
Measured: 1 year
Secondary outcomes (2)
The time taken from randomisation in the A&E to making the diagnosis (if any) in each group
Measured: 1 Year
The cost of achieving a diagnosis in each group
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PalpitationsStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Schilling, MD, FRCP, Principal investigator, Barts and the London NHS Trust, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170559
- Sponsor's protocol ID
- 006628 BLT
- Acronym
- LIAISE
- Status last verified
- Aug 2014
- First submitted
- 26 Jul 2010
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Implantable Loop Recorders as a Primary Investigation of Infrequent Undiagnosed ArrhythmIa Symptoms in the Emergency Department
- ClinicalTrials.gov ID
- NCT01170559
- Acronym / sponsor ID
- LIAISE / 006628 BLT
- Conditions
- Palpitations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Jul 2010 (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.
Heart rhythm abnormalities underlie one of the common presenting complaints to the A\&E and out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having symptoms, it is very difficult to determine the cause of the palpitations. The conventional approach is to refer these patients from the emergency departments to the Cardiology outpatients where they undergo repeated short term rhythm monitoring hoping to record the rhythm underlying the patient's complaint. Unfortunately, this often yields no results thus delaying definitive treatment and incurring extra costs of repeated investigations and A\&E presentations. This study aims to compare the ability of the conventional approach to establish a definite diagnosis compared to that of an early invasive monitoring approach with a small implantable device that records the heart rhythm at all time for up to 18 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: ILR Group | Experimental | Device: Implantable Loop RecorderGroup allocated to receiving an ILR in the A\&E department. |
| Group 2: Conventional | No intervention | –Group randomised to conventional lines of investigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness)
- Terminates before presentation to hospital
- Episodes occur at a frequency of less than once every two weeks
- Never previously caught on ECG or ambulatory monitoring
Key exclusion criteria (7 listed)
- Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR >1.6, ongoing infection, sepsis or fever, etc.
- Palpitations suggestive of extrasystoles (single missed or dropped beats)
- Known or suspected severe valvular or myocardial heart disease
- Thyrotoxicosis
- Patients who refuse an ILR when offered will not be included in either limb of 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 |
|---|---|---|
| Implantable Loop RecorderAlso: Reveal XT | Device | Group 1: ILR Group |
Primary outcome
The primary endpoint of the study is the proportion of patients achieving a definite diagnosis in each of the two groups at the end of one year
Time frame: 1 year
2 secondary outcomes
The time taken from randomisation in the A&E to making the diagnosis (if any) in each group
Time frame: 1 Year
The cost of achieving a diagnosis in each group
Time frame: 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 5 Jan 2023.
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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.
Richard Schilling, MD, FRCP principal investigator
Barts and the London NHS Trust, Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Loop Recorder in people with Palpitations, run by Barts & The London 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 6 inclusion and 7 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 5 Jan 2023. 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?
The primary endpoint of the study is the proportion of patients achieving a definite diagnosis in each of the two groups at the end of one year (time frame: 1 year). 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 5 Jan 2023.