Skip to main content
OpenTrials
Completed

NCT Number: NCT01170559

Use of Loop Recorders for Diagnosis of Palpitations in A&E

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Palpitations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barts and the London NHS Trust

London, EC1A 7BE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Loop Recorder

Device

Other names: Reveal XT

Primary outcomes

  1. 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

Secondary outcomes

  1. The time taken from randomisation in the A&E to making the diagnosis (if any) in each group

    Time frame: 1 Year

  2. The cost of achieving a diagnosis in each group

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

Use of Implantable Loop Recorders as a Primary Investigation of Infrequent Undiagnosed ArrhythmIa Symptoms in the Emergency Department

Acronym: LIAISE

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jul 27, 2010
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.