Sternal ECG Patch Comparison Trial

NCT ID: NCT02126631

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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The purpose of this research is to simplify the system of recording ECGs. Carnation Ambulatory Monitoring (CAM) System is a small patch system that can be worn during most activities include showering. Each patient will be his or her own control, and will wear the CAM and Holter systems simultaneously for 24 hours. Both systems will then be sent out for analysis.

Conditions

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Syncope Presyncope Palpitations Atrial Fibrillation Supraventricular Tachycardia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Syncope of uncertain etiology or
* Pre-syncope of uncertain etiology or
* Palpitations of uncertain etiology or
* Management of known AF/SVT patients

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bardy Diagnostics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon Hunt, PhD

Role: STUDY_DIRECTOR

Bardy Diagnostics, Inc. (sponsor)

Warren Smith, MBChB

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Locations

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Auckland City Hospital

Auckland, , New Zealand

Site Status

Countries

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New Zealand

Facility Contacts

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Warren Smith, MBChB

Role: primary

+64 (021) 774 140

Other Identifiers

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6147

Identifier Type: -

Identifier Source: org_study_id

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