Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517023
Status:
UNKNOWN
Last Update Posted:
2008-05-09
First Post:
2007-08-15
Brief Title:
Eastbourne Syncope Assessment Study II
Sponsor:
Eastbourne General Hospital
Organization:
Eastbourne General Hospital
Study Overview
Official Title:
Eastbourne Syncope Assessment Study II
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EaSyAS II
Brief Summary:
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 patients 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 ie 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
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 patients 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 ie 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:
The original EaSyAS study 1998 evaluated the use of implantable loop recorders ILRs in the diagnosis and management of syncopeThis 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 25 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 fallssyncope clinic potentially improving cost effective diagnosis and management of syncope
ILRs will be implanted without patient admission and with follow up in a syncopefalls 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
The Post-EaSyAS study evaluated extended 25 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 fallssyncope clinic potentially improving cost effective diagnosis and management of syncope
ILRs will be implanted without patient admission and with follow up in a syncopefalls 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| T07-015 | None | None | None |