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

The recruitment status of this study is unknown because the information has not been verified recently.
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • The cost of achieving a diagnosis in each group [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:   Both
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
Health Authority: United Kingdom: Barts and the London NHS Trust
United Kingdom: Camden and Islington Research Ethics Committee

ClinicalTrials.gov processed this record on September 23, 2016