Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2007-08-31
2009-08-31
Brief Summary
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While the causes of syncope encompass a wide variety of factors, those due to heart rhythm abnormalities are acknowledged to be significantly more serious compared with other causes.
The main aim of the study is to see if it is possible to find the cause of a patient's syncope faster using a device called an implantable loop recorder (ILR), which is implanted under the skin, versus conventional management. The device is slightly larger than a 50 pence coin and records the rhythm of the heart continuously.
Although ILRs are being used widely today, we want to use a new model that is able to relay information to the doctor via wireless technology and internet.
We also want to use ILRs earlier in diagnosing syncope, thereby avoiding unnecessary and lengthy hospital admissions and lowering cost.
Primary aim: To see how soon the ILR detects abnormal heart rhythms or normal ones (in study subjects who faint/ suffer syncope).
Secondary aims are:
1. To see how soon treatment is started once the abnormal rhythm is detected by the ILR.
2. To see which group (patients with ILRs or those receiving conventional tests) receives treatment sooner.
3. To see which group has less subsequent collapses i.e has benefited from appropriate treatment sooner.
4. To assess the cost effectiveness of using the implantable loop recorder more as a diagnostic tool for syncope versus conventional management (it should save many hospital admissions).
Detailed Description
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The "Post-EaSyAS" study evaluated extended (2.5 years) follow up of these patients. The "Tis-EaSyAS" study evaluated 3 different tilt protocols with long term ILR follow up describing the positive predictive value of tilt testing in unexplained syncope.
The EaSyAS II study elaborates further the above by using the ILR to avoid hospital admission and optimise the use of a falls/syncope clinic, potentially improving cost effective diagnosis and management of syncope.
ILRs will be implanted without patient admission and with follow up in a syncope/falls assessment clinic, compared to optimal protocol driven current management.
The ILR used has capabilities to record and transmit heart rhythm abnormalities to a wireless receiver which will then relay the information to the clinician via the internet. It is hoped that this will shorten diagnosis times and speed up commencement of treatment for patients, and will avoid expensive tests and more expensive hospital admissions.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
DIAGNOSTIC
NONE
Study Groups
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ILR + Syncope Clinic
Patients will have ILR implanted and follow-up in Syncope Clinic
Sleuth Implantable Loop Recorder
ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)
ILR Only
Patients will have ILR implanted and routine follow up.
Sleuth Implantable Loop Recorder
ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)
Routine Mx + Syncope Clinic
Patients will receive routine care and management plus follow up in Syncope Clinic
Other
Routine care and tests usually offered for syncope patients.
Routine Mx
Patients will receive routine care and management
Other
Routine care and tests usually offered for syncope patients.
Interventions
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Sleuth Implantable Loop Recorder
ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)
Other
Routine care and tests usually offered for syncope patients.
Eligibility Criteria
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Inclusion Criteria
* Acute syncope presentation to MAU or A+E
* 2 or more unexplained syncopes within the past 24 months including index episode
* Normal baseline ECG
* Absence of co - existing pathology requiring admission
Exclusion Criteria
* ECG abnormalities suspected of arrhythmic syncope listed in Table 1
* Syncope occurring during exercise
* Syncope causing severe injury
* Family history of sudden death
* Sudden onset palpitations prior to syncope
Table 1: ECG Abnormalities:
* Bifascicular block (defined as LBBB or RBBB combined with left anterior or left posterior fascicular block)
* Other intraventricular abnormalities (QRS duration \>= 0.12s)
* Mobitz 1 second degree AV block (Wenckebach)
* Asymptomatic sinus bradycardia (\<50 bpm), SA node or sinus pause \>= 3s in the absence of negatively chronotropic medications
* Pre-excited QRS with short PR interval (WPW)
* Significantly Prolonged QT interval
* RBBB pattern with ST elevation in V1 - V3 (Brugada Syndrome)
* Negative T waves with ST segment elevation in right precordial leads suggestive of arrythmogenic right ventricular dysplasia
* Significant Q waves (\>= 0.02s) suggestive of MI
16 Years
ALL
No
Sponsors
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Transoma Medical
INDUSTRY
East Sussex National Health Service Trust, United Kingdom
UNKNOWN
Eastbourne General Hospital
OTHER
Responsible Party
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Cardiac Department, Eastbourne General Hospital
Principal Investigators
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A N Sulke, DM FRCP FESC FACC
Role: PRINCIPAL_INVESTIGATOR
Eastbourne General Hospital
Locations
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Cardiology Department, Eastbourne General Hospital
Eastbourne, East Sussex, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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T07-015
Identifier Type: -
Identifier Source: secondary_id
07/Q1907/13
Identifier Type: -
Identifier Source: org_study_id