Use of Loop Recorders for Diagnosis of Palpitations in A&E (LIAISE)
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ClinicalTrials.gov Identifier: NCT01170559 |
Recruitment Status
: Unknown
Verified August 2014 by Barts & The London NHS Trust.
Recruitment status was: Active, not recruiting
First Posted
: July 27, 2010
Last Update Posted
: August 13, 2014
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Condition or disease | Intervention/treatment | Phase |
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Palpitations | Device: Implantable Loop Recorder | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Use of Implantable Loop Recorders as a Primary Investigation of Infrequent Undiagnosed ArrhythmIa Symptoms in the Emergency Department |
Study Start Date : | April 2010 |
Estimated Primary Completion Date : | August 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Group 1: ILR Group
Group allocated to receiving an ILR in the A&E department.
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Device: Implantable Loop Recorder
Other Name: Reveal XT
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No Intervention: Group 2: Conventional
Group randomised to conventional lines of investigation
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170559
United Kingdom | |
Barts and the London NHS Trust | |
London, United Kingdom, EC1A 7BE |
Principal Investigator: | Richard Schilling, MD, FRCP | Barts and the London NHS Trust, Queen Mary University of London |
Responsible Party: | Barts & The London NHS Trust |
ClinicalTrials.gov Identifier: | NCT01170559 History of Changes |
Other Study ID Numbers: |
006628 BLT |
First Posted: | July 27, 2010 Key Record Dates |
Last Update Posted: | August 13, 2014 |
Last Verified: | August 2014 |