Sternal ECG Patch Comparison Trial

Comparison of a Sternal ECG Patch With a Standard Recording System for Holter Monitoring

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02126631

Enrollment

Registered

2014-04-30

Start date

2014-07-31

Completion date

2014-07-31

Last updated

2014-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Palpitations, Presyncope, Supraventricular Tachycardia, Syncope

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
ECG signal quality	24 hours of patient use, plus shipping and analysis time ~ 2 weeks	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.

Secondary

Measure	Time frame	Description
Device comfort	24 hours	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.

Countries

New Zealand

Outcome results