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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2014 by Barts & The London NHS Trust.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Barts & The London NHS Trust

ClinicalTrials.gov Identifier:

NCT01170559

First received: July 26, 2010

Last updated: August 12, 2014

Last verified: August 2014

History of Changes

Purpose

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.

Condition	Intervention
Palpitations	Device: Implantable Loop Recorder


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:

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 Outcome Measures:

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 ]


Estimated Enrollment:	56
Study Start Date:	April 2010
Estimated Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1: ILR Group Group allocated to receiving an ILR in the A&E department.	Device: Implantable Loop Recorder Other Name: Reveal XT
No Intervention: Group 2: Conventional Group randomised to conventional lines of investigation

Eligibility


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

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170559

Locations


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

Sponsors and Collaborators

Barts & The London NHS Trust

Investigators


Principal Investigator:	Richard Schilling, MD, FRCP	Barts and the London NHS Trust, Queen Mary University of London

More Information


Responsible Party:	Barts & The London NHS Trust
ClinicalTrials.gov Identifier:	NCT01170559 History of Changes
Other Study ID Numbers:	006628 BLT
Study First Received:	July 26, 2010
Last Updated:	August 12, 2014

ClinicalTrials.gov processed this record on July 25, 2017

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