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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02126631




Registration number
NCT02126631
Ethics application status
Date submitted
28/04/2014
Date registered
30/04/2014
Date last updated
26/06/2014

Titles & IDs
Public title
Sternal ECG Patch Comparison Trial
Scientific title
Comparison of a Sternal ECG Patch With a Standard Recording System for Holter Monitoring
Secondary ID [1] 0 0
6147
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syncope 0 0
Presyncope 0 0
Palpitations 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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ECG signal quality - ECG signal quality = scoring the ability of each system to record electrical activity from the atrium (P-waves). The Physician Event Committee will independently score the P-waves from all recordings, using the following scale: Excellent, Good, Fair, Poor, Non-existent. Diagnostic yield will also be assessed.
Timepoint [1] 0 0
24 hours of patient use, plus shipping and analysis time ~ 2 weeks
Secondary outcome [1] 0 0
Device comfort - Secondary outcome measures will include Human Factors performance of the 2 systems, which will be scored and compared in the following areas and duration of patch adherence: skin irritation, comfort, contact and stability.
Timepoint [1] 0 0
24 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any dermatitis or infected skin over the sternum (Carnation patch) or left upper
anterior thorax (Zio patch).

- A sternal or thoracic incision that extends under the patch within 3 months from the
date of enrollment

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bardy Diagnostics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a
patch monitoring system, with the Holter monitoring system. Holters represent the current
standard for continuous recording of the ECG over extended periods.
Trial website
https://clinicaltrials.gov/show/NCT02126631
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jon Hunt, PhD
Address 0 0
Bardy Diagnostics, Inc. (sponsor)
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02126631