Sternal ECG Patch Comparison Trial

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02126631
• Other study ID #: 6147
• Status: Not yet recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: June 25, 2014
• Start date: July 2014
• Est. completion date: July 2014

Study information

• Verified date: June 2014
• Source: Bardy Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics CommitteesNew Zealand: Medsafe
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Palpitations
• Presyncope
• Supraventricular Tachycardia
• Syncope
• Tachycardia
• Tachycardia, Supraventricular

Locations

Country	Name	City	State
New Zealand	Auckland City Hospital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Bardy Diagnostics, Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours of patient use, plus shipping and analysis time ~ 2 weeks	No
Secondary	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.	24 hours	Yes