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

NCT ID: NCT01170559

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2016-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group 1: ILR Group

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

Group Type: EXPERIMENTAL

Implantable Loop Recorder

Intervention Type: DEVICE

Group 2: Conventional

Group randomised to conventional lines of investigation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Implantable Loop Recorder

Intervention Type: DEVICE

Other Intervention Names

Reveal XT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Schilling, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Barts and the London NHS Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

006628 BLT

Identifier Type: -

Identifier Source: org_study_id