Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02952781
Other study ID # CZ2016
Secondary ID
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A