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

NCT02952781 | Completed

• 1 other identifier: CZ2016
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Syncope; Presyncope; Atrial Fibrillation; Supraventricular Tachycardia

Keywords

ECG Monitoring; Palpitations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Skin comfort or discomfort: Was skin irritated?

  7 days

• Device Comfort

  7 days

• Device Stability and Contact

  7 days

• Diagnostic Yield

  7 days

Interventions

EKG Patch monitors (Zio and Carnation) DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac patients followed at the study site's location.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EvergreenHealth: lead

Study Sites (1)

EvergreenHealth Heart and Vascular Care

Kirkland, Washington, 98034, United States

Location

Related 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.

  PMID: 2331188 RESULT

• 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. doi: 10.2143/AC.55.3.2005733.

  PMID: 10902039 RESULT

• 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. doi: 10.1017/s0317167100051933.

  PMID: 10676584 RESULT

• 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. doi: 10.1136/hrt.58.3.251.

  PMID: 3663425 RESULT

• 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. doi: 10.1016/0002-9343(93)90329-n.

  PMID: 8238063 RESULT

• 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. doi: 10.1378/chest.77.6.722.

  PMID: 7398383 RESULT

• 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. doi: 10.1097/00007611-199001000-00013.

  PMID: 2300833 RESULT

MeSH Terms

Conditions

Syncope; Atrial Fibrillation; Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Mark Vossler, MD

  Evergreenhealth Heart and Vascular Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: November 2, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)