Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
24 hours of patient use, plus shipping and analysis time ~ 2 weeks
Secondary outcome [1] 0 0
Device comfort
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
Sex
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
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2014
Actual
Sample size
Target
50
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/study/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/study/NCT02126631