An interventional study of Sleuth Implantable Loop Recorder and Other in Syncope, sponsored by Eastbourne General Hospital. Status unknown at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2008-05-09.
Sponsored by Eastbourne General Hospital · Not applicable, Interventional, and Diagnostic
Syncope (commonly called collapses or blackouts) is defined as loss of consciousness which is transient, self limiting and usually leads to falling.
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:
The original EaSyAS study (1998) evaluated the use of implantable loop recorders (ILRs) in the diagnosis and management of syncope.This demonstrated a significant increase in successful diagnosis following use of implantable loop recorders. Here there were 442 syncope admissions to Eastbourne in 2001. Diagnostic rate was 42%. In addition, time to diagnosis was quicker and therefore so was introduction of therapy. This resulted in significant increase in time to recurrent syncopal episodes and improved general wellbeing in an unselected population with syncope of an unknown cause.
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.
226 studies on the registry are indexed under Syncope; 45 are open to participants now.
This study's planned enrollment of 240 is above the median of 79 across 126 interventional studies indexed under Syncope.
Browse Syncope studies →Eastbourne General Hospital is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Table 1: ECG Abnormalities:
Patients will have ILR implanted and follow-up in Syncope Clinic
Device: Sleuth Implantable Loop Recorder
Patients will have ILR implanted and routine follow up.
Device: Sleuth Implantable Loop Recorder
Patients will receive routine care and management plus follow up in Syncope Clinic
Other: Other
Patients will receive routine care and management
Other: Other
ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)
Routine care and tests usually offered for syncope patients.
Primary Outcome 1. Time to ECG (objective) diagnosis of syncope
Time frame: 1 Year
1. Time to ECG directed therapy. 2. Time to introduction of empiric therapy. 3. Time to first post induction syncope. 4. Cost effectiveness analysis.
Time frame: 1 Year
This study is status unknown, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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Eastbourne General Hospital