Use of Loop Recorders for Diagnosis of Palpitations in A&E (LIAISE)

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.

Study Overview

• Status: Completed
• Conditions: Palpitations
• Intervention / Treatment: Device: Implantable Loop Recorder

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Barts and the London NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: ILR Group; Group allocated to receiving an ILR in the A&E department.	Device: Implantable Loop Recorder; Other Names: Reveal XT
No Intervention: Group 2: Conventional; Group randomised to conventional lines of investigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 006628 BLT