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Eastbourne Syncope Assessment Study II

NCT00517023 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2008-05-09

No results posted yet for this study

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 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).

Conditions

  • Syncope

Interventions

DEVICE

Sleuth Implantable Loop Recorder

ILR insertion under aseptic conditions in left pectoral region (local anaesthetic procedure only)

OTHER

Other

Routine care and tests usually offered for syncope patients.

Sponsors & Collaborators

  • Transoma Medical

    collaborator INDUSTRY

  • East Sussex National Health Service Trust, United Kingdom

    collaborator UNKNOWN

  • Eastbourne General Hospital

    lead OTHER

Principal Investigators

  • A N Sulke, DM FRCP FESC FACC · Eastbourne General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-07-31
Completion
2009-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00517023 on ClinicalTrials.gov