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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ILR Group | Experimental | Group allocated to receiving an ILR in the A&E department. |
|
| Group 2: Conventional | No Intervention | Group randomised to conventional lines of investigation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Loop Recorder | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The time taken from randomisation in the A&E to making the diagnosis (if any) in each group | 1 Year | |
| The cost of achieving a diagnosis in each group | 1 Year |
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Inclusion Criteria:
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)
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
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| Name | Affiliation | Role |
|---|---|---|
| Richard Schilling, MD, FRCP | Barts and the London NHS Trust, Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts and the London NHS Trust | London | EC1A 7BE | United Kingdom |
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