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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01382953




Registration number
NCT01382953
Ethics application status
Date submitted
24/06/2011
Date registered
27/06/2011
Date last updated
10/01/2012

Titles & IDs
Public title
The Simple ECG Monitoring Trial (Comparison of a Novel Recording System With a Standard Holter Monitor)
Scientific title
The Simple ECG Monitoring Trial (Comparison of a Simple ECG Recording System With a Standard ECG Recording System for Holter Monitoring)
Secondary ID [1] 0 0
10131-01B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syncope 0 0
Pre-syncope 0 0
Atrial Fibrillation 0 0
Supraventricular Tachycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Standard Holter/Investigational patch

Treatment: Devices: Standard Holter/Investigational patch
The standard Holter and Investigational patch will be worn simultaneously for 24 hours. A single follow-up visit will follow in 2 days to remove both systems which will be sent away for analysis with the results of the standard system used, if pertinent, for patient management.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare the *diagnostic yield and *ECG signal quality of the standard Holter with that of the Simple ECG Monitoring patch
Timepoint [1] 0 0
24 Hours
Secondary outcome [1] 0 0
Skin comfort or discomfort: Was skin irritated?
Timepoint [1] 0 0
48 Hours
Secondary outcome [2] 0 0
Device comfort
Timepoint [2] 0 0
48 Hours
Secondary outcome [3] 0 0
Device stability and contact
Timepoint [3] 0 0
48 Hours
Secondary outcome [4] 0 0
User interface
Timepoint [4] 0 0
48 Hours

Eligibility
Key inclusion criteria
* Syncope of uncertain etiology or
* Pre-syncope of uncertain etiology or
* Palpitations of uncertain etiology or
* Management of known AF/SVT patients
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any abnormal or friable skin over the anterior thorax and upper abdomen
* Sternal incision within 3 months from the date of enrollment

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Washington
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Seattle Institute for Cardiac Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cardiac Science Corporation.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gust H. Bardy, MD
Address 0 0
Seattle Institute for Cardiac Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01382953