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

NCT01170559 | Completed

• 1 other identifier: 006628 BLT
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Palpitations

Outcome Measures

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

  1 year

Secondary Outcomes (2)

• 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

Study Arms (2)

Group 1: ILR Group

EXPERIMENTAL

Group allocated to receiving an ILR in the A\&E department.

Device: Implantable Loop Recorder

Group 2: Conventional

NO INTERVENTION

Group randomised to conventional lines of investigation

Interventions

Implantable Loop Recorder DEVICE

Also known as: Reveal XT

Group 1: ILR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts and the London NHS Trust

London, EC1A 7BE, United Kingdom

Location

Study Officials

• Richard Schilling, MD, FRCP

  Barts and the London NHS Trust, Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 5, 2023

Record last verified: 2014-08

Locations

GB (1)