deltatrials
Unknown NA INTERVENTIONAL 4-arm NCT00517023

Eastbourne Syncope Assessment Study II (EaSyAS II)

Sponsor: East Sussex National Health Service Trust, United Kingdom

Conditions Syncope
Updated 6 times since 2017 Last updated: May 6, 2008 Started: Aug 31, 2007 Primary completion: Jul 31, 2008 Completion: Aug 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Syncope and is currently ongoing. East Sussex National Health Service Trust, United Kingdom leads this study, which shows 6 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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...

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown NA

  2. Sep 2024 — Present [monthly]

    Unknown NA

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown NA

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status NA

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status NA

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Unknown Status NA

    First recorded

Aug 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • East Sussex National Health Service Trust, United Kingdom
  • Eastbourne General Hospital
  • Transoma Medical
Data source: Eastbourne General Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations