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: Completed

Administrative data

• NCT number: NCT02952781
• Other study ID #: CZ2016
• Status: Completed
• Phase: N/A
• First received: October 13, 2016
• Last updated: March 3, 2017
• Start date: October 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: EvergreenHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to test the clinical value of a new P-wave sensitive recording vector compared to a standard ECG limb lead II vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM system improves arrhythmia diagnosis.

Description:

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. The primary endpoint for this comparison will be diagnostic yield with secondary endpoints being ease of use and comfort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female

• Written informed consent

• Patients with one or more of the following:

• 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.

• Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing

Related Conditions & MeSH terms

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

Intervention

Device:
• EKG Patch monitors (Zio and Carnation)
Each patient will be provided with both a Zio-XT Patch monitoring system and the CAM system and will be instructed to wear both simultaneously for 7 days.

Locations

Country	Name	City	State
United States	EvergreenHealth Heart and Vascular Care	Kirkland	Washington

Sponsors (1)

Lead Sponsor	Collaborator
EvergreenHealth

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bass EB, Curtiss EI, Arena VC, Hanusa BH, Cecchetti A, Karpf M, Kapoor WN. The duration of Holter monitoring in patients with syncope. Is 24 hours enough? Arch Intern Med. 1990 May;150(5):1073-8. — View Citation

Bell C, Kapral M. Use of ambulatory electrocardiography for the detection of paroxysmal atrial fibrillation in patients with stroke. Canadian Task Force on Preventive Health Care. Can J Neurol Sci. 2000 Feb;27(1):25-31. Review. — View Citation

Brown AP, Dawkins KD, Davies JG. Detection of arrhythmias: use of a patient-activated ambulatory electrocardiogram device with a solid-state memory loop. Br Heart J. 1987 Sep;58(3):251-3. — View Citation

Calkins H, Byrne M, el-Atassi R, Kalbfleisch S, Langberg JJ, Morady F. The economic burden of unrecognized vasodepressor syncope. Am J Med. 1993 Nov;95(5):473-9. — View Citation

Clark PI, Glasser SP, Spoto E Jr. Arrhythmias detected by ambulatory monitoring. Lack of correlation with symptoms of dizziness and syncope. Chest. 1980 Jun;77(6):722-5. — View Citation

Clinical value of vectorcardiography, Holter monitoring and quantitative electrocardiology. Belgian Society of Cardiology. Working Group on Electrocardiology, Exercise Testing and Cardiac Rehabilitation. Acta Cardiol. 2000 Jun;55(3):157-62. Review. — View Citation

Cumbee SR, Pryor RE, Linzer M. Cardiac loop ECG recording: a new noninvasive diagnostic test in recurrent syncope. South Med J. 1990 Jan;83(1):39-43. — View Citation

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.	7 days
Secondary	Skin comfort or discomfort: Was skin irritated?	User will rate skin comfort on pre-determined scale: None, Mild, Moderate, Severe.	7 days
Secondary	Device Comfort	Was device comfortable to wear? User will rate on a predetermined scale: Very Uncomfortable, Mildly Uncomfortable, Comfortable.	7 days
Secondary	Device Stability and Contact	Did the device stay in place in the chest location where it was attached for the time period indicated? Clinician will evaluate visually, and rate on a predetermined scale: Yes, No.	7 days
Secondary	Diagnostic Yield	Diagnostic Yield: proportion of patients for whom an arrhythmogenic source of symptoms is established or eliminated as a diagnosis.	7 days