Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial

Atrial Fibrillation Clinical Trial

Official title:

Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02031484
• Other study ID #: Zio study
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 8, 2014
• Last updated: October 5, 2016
• Start date: July 2016
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Bardy Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods.

Description:

The purpose of this research is to confirm the clinical value of a new P-wave sensitive recording vector combined with an easy-to-use long-term cardiac rhythm monitoring patch system, the CarnationTM Ambulatory Monitoring (CAM) System. The P-wave is a critical aspect of the electrocardiogram and a key finding for proper arrhythmia diagnosis. The CAM system is optimized for both ease of use and for maximum P-wave clarity for arrhythmia diagnosis.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• 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
United States	Mid Carolina Cardiology	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	University of Iowa	Iowa City	Iowa
United States	Eastside Cardiology	Kirkland	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bardy Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

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.	14 days	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.	14 days	Yes