SyncopeEaSyAS IINCT00517023
Eastbourne Syncope Assessment Study II
A study testing Sleuth Implantable Loop Recorder and Other in people with Syncope, run by East Sussex Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Sleuth Implantable Loop Recorder and Other
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > = 16 yrs
- 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
Who cannot join
- Suspected or known heart disease
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cardiology Department, Eastbourne General Hospital
Eastbourne, East Sussex, BN21 2UD
About this study
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.
Read more
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:
- To see how soon treatment is started once the abnormal rhythm is detected by the ILR.
- To see which group (patients with ILRs or those receiving conventional tests) receives treatment sooner.
- To see which group has less subsequent collapses i.e has benefited from appropriate treatment sooner.
- 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).
Read the detailed description
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.
- Conditions
- Syncope
- Being tested
- Sleuth Implantable Loop Recorder, Other
- Keywords
- Implantable Loop Recorder, Home monitoring, Syncope/ Falls Clinic
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleuth Implantable Loop RecorderDevice
ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)
OtherOther
Routine care and tests usually offered for syncope patients.
| Study group | Role | What they receive |
|---|---|---|
| ILR + Syncope Clinic | Active comparator | Patients will have ILR implanted and follow-up in Syncope Clinic Receives: Device: Sleuth Implantable Loop Recorder |
| ILR Only | Active comparator | Patients will have ILR implanted and routine follow up. Receives: Device: Sleuth Implantable Loop Recorder |
| Routine Mx + Syncope Clinic | Active comparator | Patients will receive routine care and management plus follow up in Syncope Clinic Receives: Other: Other |
| Routine Mx | Active comparator | Patients will receive routine care and management Receives: Other: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome 1. Time to ECG (objective) diagnosis of syncope
Measured: 1 Year
Secondary outcomes (1)
1. Time to ECG directed therapy. 2. Time to introduction of empiric therapy. 3. Time to first post induction syncope. 4. Cost effectiveness analysis.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Transoma Medical, East Sussex National Health Service Trust, United Kingdom
- Investigators
- A N Sulke, DM FRCP FESC FACC, Principal investigator, East Sussex Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517023
- Sponsor's protocol ID
- 07/Q1907/13
- Other IDs
- T07-015
- Acronym
- EaSyAS II
- Status last verified
- May 2008
- First submitted
- 15 Aug 2007
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eastbourne Syncope Assessment Study II
- ClinicalTrials.gov ID
- NCT00517023
- Acronym / sponsor ID
- EaSyAS II / 07/Q1907/13
- Conditions
- Syncope
- Keywords
- Implantable Loop Recorder, Home monitoring, Syncope/ Falls Clinic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Transoma Medical, East Sussex National Health Service Trust, United Kingdom
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 16 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To see how soon treatment is started once the abnormal rhythm is detected by the ILR.
- To see which group (patients with ILRs or those receiving conventional tests) receives treatment sooner.
- To see which group has less subsequent collapses i.e has benefited from appropriate treatment sooner.
- 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ILR + Syncope Clinic | Active comparator | Device: Sleuth Implantable Loop RecorderPatients will have ILR implanted and follow-up in Syncope Clinic |
| ILR Only | Active comparator | Device: Sleuth Implantable Loop RecorderPatients will have ILR implanted and routine follow up. |
| Routine Mx + Syncope Clinic | Active comparator | Other: OtherPatients will receive routine care and management plus follow up in Syncope Clinic |
| Routine Mx | Active comparator | Other: OtherPatients will receive routine care and management |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age > = 16 yrs
- 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
Key exclusion criteria (16 listed)
- Suspected or known heart disease
- ECG abnormalities suspected of arrhythmic syncope listed in Table 1
- Syncope occurring during exercise
- Syncope causing severe injury
- Family history of sudden death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleuth Implantable Loop RecorderILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only) | Device | ILR + Syncope Clinic, ILR Only |
| OtherRoutine care and tests usually offered for syncope patients. | Other | Routine Mx, Routine Mx + Syncope Clinic |
Primary outcome
Primary Outcome 1. Time to ECG (objective) diagnosis of syncope
Time frame: 1 Year
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
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Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A N Sulke, DM FRCP FESC FACC principal investigator
East Sussex Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleuth Implantable Loop Recorder and Other in people with Syncope, run by East Sussex Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact A N Sulke, DM FRCP FESC FACC (+44 1323 417400 ext. 5869, neil.sulke@esht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1. Time to ECG (objective) diagnosis of syncope (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2008.